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PubMed1989

[Immune response and reactions to simultaneous administration of hepatitis B vaccine with routine vaccine in children. II. Immune response and reactions to simultaneous administration of hepatitis B vaccine with Japanese B encephalitis vaccine and measles vaccine].

This paper reports the result of the immune response and reactions to simultaneous administration of Japanese B encephalitis vaccine, measles and hepatitis B vaccine. 215 children (0-9 months of age) were divided into three groups. Group one was vaccinated with hepatitis B vaccine alone, group two was vaccinated with Japanese B encephalitis vaccine, measles vaccine, and group three was Vaccinated with hepatitis B vaccine, Japanese B encephalitis vaccine and measles vaccine simultaneously. The result of the immune response to the combination of hepatitis B vaccine with Japanese B encephalitis vaccine were similar to that observed after immunization with each vaccine alone. But the result of the immune response to the combination of hepatitis B vaccine with measles vaccine were lower than to that observed after immunization with measles vaccine alone. The general reaction of all vaccine were mild, no significant difference between each group was noted. The study demonstrated that children can not be immunized with hepatitis B vaccine and measles vaccine simultaneously but can be immunized with hepatitis B Vaccine and Japanese B encephalitis vaccine.

Encephalitis Virus, Japanese↗
PubMed2001

Surveillance for poliovirus vaccine adverse events, 1991 to 1998: impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine.

BACKGROUND: The elimination of wild-virus-associated poliomyelitis in the Western Hemisphere in 1991 and rapid progress in global polio eradication efforts changed the risk-benefit ratio associated with the exclusive use of oral poliovirus vaccine (OPV) for routine immunization. These changes, plus the November 1987 development of an enhanced-potency inactivated poliovirus vaccine (IPV), which poses no risk of vaccine-associated paralytic poliomyelitis (VAPP), resulted in a change in polio immunization policy in the United States. In September 1996, the Centers for Disease Control and Prevention recommended that IPV replace OPV for the first 2 doses in a sequential poliovirus vaccine schedule. The Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system for adverse events after receipt of any US-licensed vaccine, is used to monitor postlicensure vaccine safety. Postlicensure surveillance of vaccines is important to identify new, rare, or delayed-onset adverse reactions not detected in prelicensure clinical trials or when new vaccine schedules are adopted. Through continual monitoring of adverse events and identification of potential vaccine risks, VAERS can serve as an important resource to ensure continued public acceptance of vaccines. We compared VAERS reports after the receipt of IPV to reports after OPV in infants from 1991 through 1998. Comparisons included reports listing IPV and OPV coadministered with other vaccines. METHODS: Annual reporting rates per 100 000 doses distributed within 3 severity categories (fatal, nonfatal serious, less serious) were examined. Distributions of severity categories by vaccine type, age, and time period (pre- and postrecommendation) were constructed. Safety profiles (distribution of 21 symptom groupings) for IPV and OPV reports were compared. Analysis was restricted to reports for infants 1 to 3 months old and 4 to 6 months old, corresponding generally to first- and second-dose recipients. Any notable increase in a severity or safety category for IPV compared with OPV was followed up by examining the frequency of specific symptoms, reporting source, and date of vaccination. An important limitation of VAERS is that reports do not necessarily represent adverse events caused by vaccines. In many cases, the events are temporal associations only. RESULTS: The annual rates of VAERS reports per 100 000 vaccine doses distributed by severity category, 1991 to 1998, were in general similar for reports after IPV compared with those after OPV. The reporting rates for poliovirus vaccine did not increase materially with the shift to IPV usage. The relative frequencies of symptoms in the fatal and nonfatal serious categories for 1998 vaccine administrations were similar to 1997 reports. Severity profiles for IPV and OPV reports in infants 1 to 3 months old and 4 to 6 months old, corresponding to first- and second-dose recipients, were remarkably similar. The frequency of symptoms listed on IPV reports categorized as fatal or serious was examined by age, vaccine combinations, and time period, and the distribution of symptoms was similar for ages 1 to 3 months and 4 to 6 months. In the postrecommendation period, the 10 most frequent symptoms reported with IPV were also reported with OPV in either similar or lower relative frequency. During the postrecommendation period, safety profiles for infants 4 to 6 months old showed a 2.5% higher proportion in the allergic reaction category for IPV than for OPV, but none of the allergic reaction reports indicated anaphylaxis. In general, the distribution of symptom groupings was not markedly different for IPV compared with OPV. No cases of VAPP were reported after the administration of IPV, whereas 5 VAPP cases were reported after the administration of OPV. CONCLUSIONS: Although VAERS is subject to the limitations of most passive surveillance systems, the large number of reports and national coverage provide a unique database for monitoring vaccine safety. There was a marked increase of IPV reports in VAERS after 1996, consistent with implementation of the Advisory Committee on Immunization Practices recommendation for the sequential IPV/OPV poliovirus vaccination schedule. Given the increased use of IPV, a review of potential adverse events in VAERS compared IPV with OPV reports both before and after the introduction of the sequential vaccination schedule. Vaccine safety surveillance indicated no adverse events patterns of potential concern following the use of IPV in infants after the introduction of the sequential vaccination schedule. Ongoing surveillance is documenting a decrease in VAPP. These findings provide useful information to support the Advisory Committee on Immunization Practices recommendation, made in 1999, to shift to an all-IPV schedule.

Adverse Drug Reaction Reporting Systems↗
PubMed1990

[Immune response and post inoculation reactions of simultaneous administration of hepatitis B vaccine with routine vaccine in children, III. Immune response and post inoculation reactions of simultaneous administration of hepatitis B vaccine and BCG, meningococcus group A polysaccharide vaccine].

The results of the immune response and post inoculation reactions of simultaneous administration of BCG, meningococcus group A polysaccharide vaccine and hepatitis B vaccine were reported. 360 newborn babies (1-3 days of age) were divided into five groups. The babies in group No. 1 were vaccinated with hepatitis B vaccine alone, babies in group No. 2 were vaccinated with BCG for scarification within 3 days after delivery and meningococcus group A polysaccharide vaccine in 6 months of age; babies in group No. 3 were vaccinated with hepatitis B vaccine, BCG for scarification and Meningococcus group A polysaccharide vaccine simultaneously, babies in group No. 4 were vaccinated with intradermal BCG and Meningococcus group A polysaccharide vaccine separately, babies in group No. 5 were vaccinated with hepatitis B vaccine, intradermal BCG and meningococcus group A polysaccharide vaccine simultaneously. The results of the immune response of the combination of hepatitis B vaccine with BCG, meningococcus group A polysaccharide vaccine were similarly to the immune response observed after immunization of each vaccine alone in children. The general post inoculation reactions of all vaccines were mild. There was no significant difference among all 5 groups. The data showed that children could be immunized with hepatitis B vaccine, BCG and meningococcus group A polysaccharide vaccine simultaneously.

Antibodies, Viral↗
PubMed2003

HIV gp120 vaccine - VaxGen: AIDSVAX, AIDSVAX B/B, AIDSVAX B/E, HIV gp120 vaccine - Genentech, HIV gp120 vaccine AIDSVAX - VaxGen, HIV vaccine AIDSVAX - VaxGen.

VaxGen is developing prophylactic vaccines against HIV-1 consisting of two recombinant gp120 surface proteins from different HIV-1 strains.This profile has been selected from R&D Insight, a pharmaceutical intelligence database produced by Adis International Ltd. The bivalent vaccines [AIDSVAX B/B and AIDSVAX B/E] are being evaluated in two phase III trials. The first multicentre phase III trial of AIDSVAX B/B, was conducted principally in Canada and the US but also at some sites in the Netherlands and Puerto Rico. The trial was completed at the end of 2002. The second phase III trial is being conducted in Thailand with the AIDSVAX B/E vaccine. VaxGen announced in July 2002 that it would be delaying its Biologics License Application (BLA) for AIDSVAX until 2004 to enable the company to fulfil pre-approval manufacturing requirements. AIDSVAX is based on an earlier monovalent gp120 vaccine developed by Genentech that was shown to be safe in humans. VaxGen (formerly Genenvax) was formed as a spin-off company from Genentech with the sole purpose of developing the gp120 vaccine. VaxGen announced in July 2002 that the original License and Supply agreement with Genentech, signed in May 1997, had been amended. Under the revised agreement, Genentech maintains its right to market and sell AIDSVAX in North America, but has relinquished its options to commercialise the vaccine candidate in the rest of the world. Genentech's earlier decision to waive its option to manufacture AIDSVAX has also been formalised in this agreement. Additionally, VaxGen's royalty payments to Genentech for sales to the WHO or UN for underdeveloped nations have also been reduced by up to 50% and Genentech has extended the milestone date associated with VaxGen submitting an NDA. A $US120 million joint venture (Celltrion) has been formed between VaxGen and South Korean investors to manufacture more than 200 million doses of AIDSVAX a year. Celltrion will build and operate two biotechnology manufacturing facilities: a pilot plant in South San Francisco and a larger plant in Incheon, South Korea. VaxGen will retain a 44% interest in the new company, as well as any profit generated by the AIDS vaccine. If AIDSVAX wins regulatory approval, VaxGen is committed to purchasing a minimum of 87 million doses a year. Celltrion announced in July 2002 that it had acquired 24 acres of land in Incheon, South Korea, for the site of its major biologics manufacturing facility. The facility is scheduled to be ready for commercial operation by 2005. The US FDA granted fast-track designations to the two vaccines AIDSVAX B/B and AIDSVAX B/E in December 2002. The study volunteers included 5108 men who have sex with men and 309 at-risk women, all of whom were meant to be HIV negative when they joined the trial. During the 36-month trial, a total of seven injections were administered at months 0, 1, 6, 12, 18, 24 and 30. The ratio of vaccine to placebo recipients was 2:1. On February 24 2003, VaxGen announced that AIDSVAX B/B did not prove effective in the trials conducted in North America and Europe. The study did not show a statistically significant reduction of HIV infection within the study population as a whole, which was the primary endpoint of the trial. However, the study did show a statistically significant reduction of HIV infection in certain vaccinated groups. Trial data indicate that black and Asian volunteers appeared to produce higher levels of antibodies against HIV. White and Hispanic volunteers appeared to develop consistently lower levels of protective antibodies following vaccination. VaxGen intends to conduct additional analyses to confirm if there was a direct correlation between the level of antibodies and the prevention of infection. The company intends to continue development of the vaccine through licensure, including any studies necessary to evaluate the protective riticism in the media about the statistical analysis of the non-Caucasian data, VaxGen issued a statement on 27 February 2003 claiming that the analysis of data from the trial followed a statistical analysis plan that was agreed on in advance with the US FDA. The plan included analyses of various subgroups, including racial backgrounds. Subsequently, VaxGen presented further analyses of the phase III data at the Keystone Symposia on 31 March 2003, and stated that the differences in vaccine efficacy observed between the Caucasian and non-Caucasian (Black, Asian and other) vaccinees could not have been due solely to chance. In May 2003, VaxGen stated that it would only continue developing AIDSVAX if government agencies and philanthropic organisations provide the necessary funding. AIDSVAX B/E is designed to protect against strains of HIV-1 prevalent in Indonesia, Japan, Korea, Taiwan and Thailand. Like the North American study, this trial also includes an interim efficacy analysis, set for 24 months after completion of enrolment. Results from this trial are expected to be announced in the second half of 2003. This trial received its final favourable review from the DSMB in October 2002. Based on this result, the National Institute of Allergy and Infectious Disease (NIAID) has decided to pursue only one of the two previously planned phase III trials involving immunisation with vCP1452 and AIDSVAX B/B. The NIAID will not conduct the North and South American phase III trial. It will, however, proceed with the planned 'prime-boost' phase III trial in Thailand, to evaluate the efficacy of a similar vaccine combination, ALVAC-HIV-vCP1521 and AIDSVAX B/E, both of which incorporate envelope antigens from the predominant circulating HIV (CRF_AE_01) in Thailand. The trial is expected to begin enrolling volunteers in March 2003. VaxGen was a awarded $US3.3 million contract to supply AIDSVAX B/E for the trial, which will be funded by the NIH and conducted by the US Army. NIAID and the HIV Trials Network (HVTN) are conducting a phase II trial (HVTN 026), testing the immunogenicity of vCP1452 alone and in combination with AIDSVAX among populations in Brazil, Haiti, Peru and Trinidad and Tobago.

AIDS Vaccines↗
PubMed1995

Effect of priming with diphtheria and tetanus toxoids combined with whole-cell pertussis vaccine or with acellular pertussis vaccine on the safety and immunogenicity of a booster dose of an acellular pertussis vaccine containing a genetically inactivated pertussis toxin in fifteen- to twenty-one-month-old children. Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.

OBJECTIVE: To evaluate the safety and the immunogenicity of a booster dose of recombinant acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP, Biocine SpA) in 15- to 21-month-old children primed in infancy with either whole-cell diphtheria-tetanus-pertussis (DTwP) vaccine or DTaP vaccine. DESIGN: Open-label second phase of a double-masked, controlled trail, with masked analysis of serum samples. PARTICIPANTS AND SETTING: Three hundred fifty children, 15 to 21 months of age, who had been primed at 2, 4, and 6 months of age with either three doses of DTaP vaccine (n = 173) or DTwP vaccine (n = 177). The children were enrolled in eight vaccination centers in Italy. INTERVENTIONS: All children received a booster dose of the DTaP vaccine and were examined for safety at 48 hours and at 7 days after vaccination. Serum samples for evaluation of immunogenicity were obtained from 196 (55%) of the 350 children. MAIN OUTCOME MEASURES: IgG antibodies to pertussis toxin (Ptox), filamentous hemagglutinin, 69-kilodalton protein, and tetanus toxoid were measured by enzyme-linked immunosorbent assay. Pertussis toxin-neutralizing antibodies were measured by the Chinese hamster ovary cell toxin neutralization assay. MAIN RESULTS: Adverse reactions to DTaP were infrequent, and there was no difference in the incidence of local or systemic reactions in children given DTaP as a fourth dose in comparison with a first dose. One month after the DTaP booster vaccination, both groups had 6- to 40-fold increases in serum antibody concentrations to all antigens tested; the concentrations against the three pertussis antigens were higher in the DTaP-primed children (p < 0.05). The antibody titers to diphtheria and tetanus toxoids were higher in the DTwP-primed group (p < 0.05), but both groups had protective titers. The geometric mean ratio of anti-Ptox neutralizing antibody per unit of IgG anti-Ptox antibody was higher in the DTaP-primed group (p < 0.001). CONCLUSIONS: There are quantitative and qualitative differences in booster responses to DTaP vaccine in young children, depending on whether they were given DTaP or DTwP as primary immunization. This DTaP vaccine is safe and highly immunogenic as a booster.

Antibodies, Bacterial↗
PubMed2002

Comparative trial to assess the reactogenicity of the diphtheria-tetanus-acellular pertussis (DTPa) vaccine plus Haemophilus influenzae type B (Hib) conjugate vaccine and that of the diphtheria-tetanus-whole cell pertussis (DTPw) vaccine plus Hib conjugate vaccine, administered in single injection a.

BACKGROUND: The diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine is being replaced in Western countries,and in several Spanish Autonomous Communities, by the diphtheria-tetanus-acellular pertussis (DTPa) vaccine. Although the administration of booster doses of DTPw or DTPa and Haemophilus influenzae type b conjugate (Hib) vaccines to toddlers is a current practice ina number of countries, there are few data comparing the reactogenicity profiles of their administration as a single injection. SUBJECTS AND METHOD: An open,prospective, randomised, multicentre trial was conducted to compare the reactogenicity profile of a single injection of DTPa and Hib vaccines (DTPa/Hib) with that of a single injection of DTPw and Hib vaccines (DTPw/Hib) as booster doses to toddlers--previously primed with DTPw and Hib vaccines. 200 children (15.1 +/-1.0 months-old) were randomised to receive DTPa/Hib (group 1;n = 101) or DTPw/Hib (group 2; n = 99) and followed up to 30 days post-vaccination. All subjects received the oral polio vaccine concomitantly. Local and general symptoms were recorded by parents on diary cards. RESULTS: Incidences of any local reaction and any general symptom < >/< >to vaccination were reported more frequently in group 2 than in group 1 (p < 0.0001). Pain at the injection site was reported by 29% and 66% of subjects in groups 1 and 2, respectively (p< 0.0001). Pain such that the child cried when limb was moved was also more frequently recorded in group 2 (15%) than in group 1 (1%) (p < 0.0001). Differences in prevalence of any swelling(16% in group 1, 30% in group 2) and swelling > 20 mm reached statistical significance (p (3/4) 0.012). Fever (rectal temperature>= 38 degrees C) was reported by 17% and 41 % in groups 1 and 2 subjects, respectively (p < 0.0001). Fussiness, loss of appetite and restlessness were also more frequently reported in DTPw/Hib subjects and reached statistical significance (at least p = 0.015).Analgesics/antipyretics were prescribed as a prophylactic treatment in only 14% of cases (9 and 19 subjects in groups 1 and 2, respectively;p = 0.0424). Antipyretic treatment after vaccination was significantly more prescribed in group 2 (27 cases) than in group 1 (8) (p <0.015). CONCLUSION: The administration of DTPa/Hib as a single injection leads to a better reactogenicity profile than the administration of DTPw/Hib, also as a single injection, as booster doses to toddlers primed with DTPw and Hib vaccines.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed1996

Concurrent oral poliovirus and rhesus-human reassortant rotavirus vaccination: effects on immune responses to both vaccines and on efficacy of rotavirus vaccines. The US Rotavirus Vaccine Efficacy Group.

Interference between oral poliovirus vaccine (OPV) and monovalent (RRV-S1) and tetravalent (RRV-TV) rhesus-human rotavirus vaccines was evaluated. Serum antibody responses to OPV and rotavirus vaccines and efficacy of rotavirus vaccines were compared among control and vaccine groups stratified by number of concurrent OPV and rotavirus vaccinations received. Neutralizing antibody titers to poliovirus type 1 tended to rise more steeply in placebo than RRV-TV recipients, but there were no significant differences in seroprevalence or in geometric mean titers (GMTs) of antibodies to types 1, 2, or 3 among groups. Concurrent OPV resulted in lower IgA GMTs to rotavirus in RRV-S1 but not RRV-TV recipients. Rotavirus gastroenteritis rates among rotavirus vaccines did not differ by number of concurrent OPV doses received, but the sample sizes were too small to rule out any effect. These results suggest OPV and rhesus-human rotavirus vaccines may be given at the same visit in the United States.

Administration, Oral↗
PubMed1983

Multivalent inactivated virus oil emulsion vaccines in broiler breeder chickens. II. Trivalent vaccines in breeders not previously vaccinated with live Newcastle disease, infectious bursal disease, and tenosynovitis vaccines.

Inactivated Newcastle disease (NDV), infectious bursal disease (IBDV), and viral arthritis/tenosynovitis (VA) viruses were incorporated into water-in-oil emulsion vaccines either alone, in bivalent combinations, or in a trivalent vaccine. Twenty-week-old broiler breeder chickens with no previous exposure to NDV, IBDV, or VA live virus vaccines were injected intramuscularly with the monovalent, bivalent, or trivalent vaccines. The antibody responses to NDV in all three vaccines were poor, and NDV-hemagglutination-inhibition (HI) geometric mean titers (GMTs) never rose above 20 during the 40-week trial. The antibody response to IBDV showed a strong primary response 4 weeks after vaccination, but IBD-VN geometric mean titers declined steadily to less than 100 by 4 months after vaccination. The antibody GMTs to IBDV continued to decline for the remainder of the trial. The antibody response to VA virus was biphasic, with peak VA-virus neutralization (VN) geometric mean titers occurring at 3 months and 6 months postvaccination. The amplitude of the response to the monovalent, bivalent, and trivalent vaccines was inversely proportional to the number of antigens incorporated into each vaccine. Maternal antibody titers in the progeny against each of the three antigens reflected those of the parents. In no case were maternal antibody titers detectable beyond 14 days of age.

Animals↗
PubMed2003

The immunogenicity of oral poliomyelitis vaccine in a primary vaccination series at 2, 4 and 6 months given concurrently with Hib, hepatitis B and diphtheria, tetanus and whole-cell pertussis vaccines administered as three separate injections or as a combination pentavalent vaccine.

The increasing number of infant immunisations has spurred development of novel combination vaccines. This investigation assesses the immunogenicity of oral poliomyelitis vaccine (OPV) under current and possible new conditions, to help ensure vaccination regimes continue to provide optimal protection against polio in the final stages of polio eradication. Neutralising antibody titres were measured in approximately 200 infants immunised with OPV at 2, 4 and 6 months in tandem with either a combined pentavalent liquid Haemophilus influenza B (Hib), hepatitis B, diphtheria, tetanus and whole-cell pertussis vaccine or three separate but concurrently administered licensed vaccines (diphtheria, tetanus and whole-cell pertussis (DTP), lyophilised Hib, and hepatitis B). Following three doses of OPV, at least 98% of infants demonstrated neutralising antibodies at 1:8 to each poliovirus type under both vaccination regimes, and geometric mean titres (GMTs) well above the suggested protective titre were also observed for all poliovirus types. OPV appears to be effective not only in producing protective antibody titres in an extremely high proportion of infants when given in combination with currently licensed vaccines, but also when administered together with the combination pentavalent vaccine under study. This is encouraging for the continued role of OPV in infant immunisation.

Administration, Oral↗
PubMed2001

Comparison of antibody kinetics following meningococcal serogroup C conjugate vaccine between healthy adults previously vaccinated with meningococcal A/C polysaccharide vaccine and vaccine-naïve controls.

Few data are available on the kinetics of meningococcal serogroup C-specific antibody production following meningococcal serogroup C conjugate (MCC) vaccination, particularly in those who have received prior meningococcal A/C polysaccharide (MACP) vaccination(s). Laboratory staff who had previously received either one dose (n = 35), two doses (n = 18) of MACP vaccine or who were naïve to previous meningococcal vaccination (n = 42) were vaccinated with MCC. Bloods were taken pre-vaccination, on the subsequent 4 days and on days 10 and 28. Serogroup C serum bactericidal antibody (SBA), and anti-serogroup C-specific IgG, IgM and IgA were measured. There were no significant differences between the groups who had received either 2 or 1 prior dose(s) of MACP, therefore, these results were combined. Up to day 4 there was no evidence of a significant increase or decrease in the median levels of SBA, IgG, IgM or IgA in either the naïve or MACP groups, although about 20% of individuals did have 4-fold SBA rises by day 4. By day 10 there were large significant increases in the levels of SBA, IgG, IgM and IgA with respective fold increases from pre-vaccination levels of 4.6, 1.9, 1.2 and 2.1 in the MACP group and 270, 13.4, 4.8 and 33.8 in the naïve group. Further significant increases were seen between day 10 and 28 for SBA, IgG and IgM (naïve group only). By day 28, 4-fold SBA rises had occurred in 63.5% of the MACP group and 97.6% of the naïve group. The SBA GMT on day 28 significantly differed between the naïve and MACP groups with GMTs 2.8-fold higher in the naïve group (P = 0.021). In conclusion, no decline in serogroup C-specific antibody levels was demonstrated immediately post-MCC vaccination whilst these levels had risen significantly by day 10. Putative protective SBA titres (> or =8, 32 or 128) were observed by day 10 following MCC vaccination regardless of MACP history.

Adult↗
PubMed1999

New vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice.

Under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers, whether public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 3, 1998, CDC published a notice in the Federal Register (63 FR 47026) seeking public comment on proposed vaccine information materials for the newly covered vaccines hepatitis B, Haemophilus influenzae type b, and varicella vaccines, and also seeking comment on proposed revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended on November 2, 1998. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials are contained in this notice.

Centers for Disease Control and Prevention, U.S.↗
PubMed1997

Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine.

We compared antibody levels following separate but simultaneous administration of diphtheria and tetanus toxoids with acellular pertussis vaccine (DTaP) containing pertussis toxoid, filamentous hemagglutinin, and pertactin (PRN); hepatitis B vaccine; and Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate; PRP) vaccine conjugated to tetanus toxoid (PRP-T) with those following administration of a combination of a DTaP-hepatitis B vaccine-PRP-T to infants at 2, 4, and 6 months of age. The antibody response to a booster dose of PRP conjugate vaccine (CRM197-OS) in infants with low (< 1 microgram/mL) or undetectable (< 0.10 microgram/mL) postpriming levels of antibody to PRP was also studied. Antibody levels were quantitated before and after dose 3 by enzyme-linked immunosorbent assay, radioimmunoassay, or neutralization assay. Seroresponse rates were not different between the two vaccine groups except for rates of response to PRP. There was a trend that levels of antibody to all the antigens included in the combination vaccine were lower than those of antibody to antigens in separate vaccines; for levels of antibody to diphtheria toxoid (P = .001), PRN (P < .0001), and PRP (P < .0001), the differences were significant. Despite low or undetectable postpriming levels of antibody to PRP, high-titered (geometric mean concentration, 9.02 micrograms/mL; range, 1.0-81.5 micrograms/mL), immunoglobulin G-predominant antibody to PRP was produced following a booster dose of CRM197-OS, a finding consistent with a memory response.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed2002

Cold-adapted live influenza vaccine versus inactivated vaccine: systemic vaccine reactions, local and systemic antibody response, and vaccine efficacy. A meta-analysis.

Since the 1940s, influenza vaccines are inactivated and purified virus or virus subunit preparations (IIV) administered by the intramuscular route. Since decades, attempts have been made to construct, as an alternative, attenuated live influenza vaccines (LIV) for intranasal administration. Presently, the most successful LIV is derived from the cold-adapted master strains A/Ann Arbor/6/60 (H2N2) and B/Ann Arbor/1/66 (AA-LIV, for Ann-Arbor-derived live influenza vaccine). It has been claimed that AA-LIV is more efficacious than IIV. In order to assess differences between the two vaccines with respect to systemic reactogenicity, antibody response, and efficacy, we performed a meta-analysis on eighteen randomised comparative clinical trials involving a total of 5000 vaccinees of all ages. Pooled odds ratios (AA-LIV versus IIV) were calculated according to the random effects model. The two vaccines were associated with similarly low frequencies of systemic vaccine reactions (pooled odds ratio: 0.96, 95% confidence interval: 0.74-1.24). AA-LIV induced significantly lower levels of serum haemagglutination inhibiting antibody and significantly greater levels of local IgA antibody (influenza virus-specific respiratory IgA assayed by ELISA in nasal wash specimens) than IIV. Yet, although they predominantly stimulate different antibody compartments, the two vaccines were similarly efficacious in preventing culture-positive influenza illness. In all trials assessing clinical efficacy, the odds ratios were not significantly different from one (point of equivalence). The pooled odds ratio for influenza A-H3N2 was 1.50 (95% CI: 0.80-2.82), and for A-H1N1, 1.03 (95% CI: 0.58-1.82). The choice between the two vaccine types should be based on weighing the advantage of the attractive non-invasive mode of administration of AA-LIV, against serious concerns about the biological risks inherent to large-scale use of infectious influenza virus, in particular the hazard of gene reassortment with non-human influenza virus strains.

Adaptation, Physiological↗
PubMed1998

Oral tetravalent rotavirus vaccine can be successfully coadministered with oral poliovirus vaccine and a combined diphtheria, tetanus, pertussis and Haemophilus influenzae type b vaccine. US Rhesus Rotavirus Vaccine Study Group.

AIM: To determine whether an oral tetravalent rotavirus vaccine (RV-TV) can be safely coadministered with a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine (DTP/Hib) and oral poliovirus vaccine (OPV) to healthy infants without interfering with the immune responses to any of the component antigens. METHODS: Two hundred sixty-seven infants ages 2 to 3 months were randomly assigned in a double blind fashion to receive three doses of either placebo or RV-TV, each containing 4 x 10(5) plaque-forming units, concurrently with DTP/ Hib (Tetramune) and OPV at approximately 2, 4 and 6 months of age. Infants were followed for 5 days after each dose for the occurrence of adverse events and subsequently until 3 to 6 weeks after the third dose of RV-TV or placebo. Immune responses were assessed by measuring the postvaccination serum antibody titers to each component of DTP/ Hib and OPV at 3 to 6 weeks after the third dose. RESULTS: The percentage of infants who attained protective antibody titers and the distribution of antibody titers against diphtheria toxoid, tetanus toxoid and H. influenzae type b were not statistically different between RV-TV and placebo recipients. The distribution of antibody titers against different antigens of Bordetella pertussis (agglutinins, pertussis toxoid, filamentous hemagglutinin, fimbriae antigens and the 69-kDa outer membrane protein) was compared and no significant differences were found. The percentage of infants with detectable neutralizing antibodies against the three serotypes of poliovirus and the distribution of antibody titers was not statistically different between RV-TV and placebo recipients. There were no clinically meaningful differences in postvaccination reactions between RV-TV and placebo recipients. CONCLUSIONS: Three doses of RV-TV can be safely coadministered with three doses of DTP/ Hib and OPV without diminishing an infant's serum antibody responses to each component of these vaccines. Therefore RV-TV can be given at the standard childhood visits at 2, 4 and 6 months of age.

Antibodies, Bacterial↗
PubMed1990

Drug interactions involving immunologic agents. Part I. Vaccine-vaccine, vaccine-immunoglobulin, and vaccine-drug interactions.

Information about immunologic drug interactions is needed by pharmacists to make rational drug-use decisions. Previously, reports of interactions involving vaccines, immune globulins, and immunodiagnostic reagents were widely dispersed. In this two-part review article, over 50 individual and categorical interactions are described, as are dozens of vaccine-vaccine and vaccine-immunoglobulin, and vaccine-drug interactions are reviewed in this first part. Vigilance by all pharmacists is needed to detect previously unreported immunologic drug interactions and to further assess known interactions.

Drug Interactions↗