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PubMed1993

Considerations for the development of recommendations for the use of hepatitis A vaccine.

The prevention of hepatitis A virus (HAV) infection should be greatly facilitated with the expected licensure of inactivated hepatitis A vaccines. In countries with a low endemicity of infection a number of high risk groups have been identified in which HAV infection occurs, and include both children and adults. In most other countries HAV infection occurs primarily in children. Thus, selective immunization of high-risk adults or children would not be expected to lower the overall rates of infection in most countries, and the eventual objective should be the integration of hepatitis A vaccine into the routine childhood immunization schedules. This would reduce disease incidence by preventing infections in children and by preventing infections in adults that are acquired from children. The elimination of a population susceptible to HAV infection through immunization could eliminate this well-known human disease, and the epidemiology of HAV infection suggests that eradication could be attainable with effective vaccines.

Hepatitis A Vaccines↗

PubMedDate not supplied

Effects of specific humoral immunity on DNA-adduct formation in Swiss mice treated with benzo[alpha]pyrene.

In order to study the effect of possible modulating factors on DNA-binding carcinogens, we investigated the role of specific immune response on racemic 7,t-8-dihydroxy-t-9,10-epoxy-7,8,9, 10-tetrahydro-benzo[a]pyrene ((+/-)-anti BPDE)-DNA (BPDE-DNA) adduct formation. Anti BPDE Immunoglobulin G (IgG) were elicited in Swiss mice before subsequent carcinogen administration. The immunization schedule consisted of four weekly subcutaneous injections of both (+/-)-anti BPDE-gelatin (BPDE-Gel) and DNA (BPDE-DNA) conjugate, followed by a final immunogen injection 14 days later. The immunization procedure resulted in the production of specific anti-BPDE antibodies in all treated animals. One week after the end of the immunization procedure, both groups of immunized and non immunized mice were treated with different doses of B[a]P (25-50-100-200 mg B[a]P/Kg body weight) by intraperitoneal injection. Seven days after treatment, the mice were sacrificed. Adduct levels were detected by competitive ELISA by using optimal conditions established in our laboratory and highly specific and sensitive IgG anti BPDE-DNA induced in rabbit. The determination of DNA adducts in liver revealed significantly lower B[a]P adduct levels in liver of immunized mice with respect to non-immunized animals. This result confirms those obtained for 2-acetylaminofluorene (2-AAF) in a previous work: the specific humoral immunity elicited by repeated carcinogen exposure may be able to modulate the genotoxic effect induced by subsequent carcinogen administration.

7,8-Dihydro-7,8-dihydroxybenzo(a)pyrene 9,10-oxide↗

PubMed2026

A multi-center, open-labelled, randomized controlled extended phase III non-inferiority clinical trial to evaluate the immunogenicity and tolerability of poliomyelitis vaccine (Vero cells), inactivated, Sabin strains administered with or without routine infant vaccines.

BACKGROUND: Oral poliovirus vaccine (OPV) has been reported to cause vaccine-derived poliovirus and vaccine-associated paralytic poliomyelitis, and the limited global supply of conventional IPV has led many countries to rely on fractional-dose IPV regimens alongside OPV. The current study aims to assess the sIPV safety and immunogenicity when given concurrently with or in a staggered manner with routine immunization. METHODS: A multi-country, multi-center, open-label, randomized controlled, extended phase III non-inferiority clinical trial was conducted with 1442 healthy infants aged 6-8 weeks from Bangladesh and Pakistan enrolled and randomized into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Antibody levels were determined using the collected sera for immunogenicity evaluation. The difference in seroconversion rates between the coadministration group and the staggered administration group is compared using the Cochran-Mantel-Haenszel χ2 (CMH-χ2) test, stratified by study site. Non-inferiority is concluded if the lower bound of the 95% confidence interval (CI) for the rate difference (coadministration group minus staggered administration group) is greater than -10%. The trial was registered prior to patient enrollment at clinicaltrials.gov (NCT05850364), and the protocol and statistical analysis plan are available at https://clinicaltrials.gov/study/NCT05850364. The trial is closed to new participants. FINDINGS: The post-vaccination seroconversion rates for PV I were 90.3% (306/339) in group C1 and 87.0% (261/300) in group S1, for PV II, 91.7% (311/339) in group C1 and 91.3% (274/300) in group S1 and for PV III, 86.4% (293/339) in group C1 and 92.3% (277/300) in group S1. Among adverse reactions (ARs) reported within 7 days of vaccination, the incidence was similarly high in both the co-administration and staggered vaccination groups (92.8% vs. 95.5%). INTERPRETATION: Our results demonstrated favorable safety and immunogenicity of co-administration of sIPV with other routine infant vaccines according to a 3-dose primary immunization schedule.

Humans↗

PubMed2006

A new combination vaccine for measles, mumps, rubella and varicella.

ProQuad is a recently approved combination vaccine for simultaneous vaccination against measles, mumps, rubella and varicella in children aged 12 months to 12 years. It combines two well-established vaccines: Measles, Mumps, Rubella Virus Vaccine Live (M-M-R II) and Varicella Virus Vaccine Live (Varivax with higher varicella-zoster titer). Whereas vaccination against measles, mumps and rubella has almost 100% coverage, vaccination against varicella shows a significantly lower uptake of approximately 84%. Clinical studies on the immunogenicity and efficacy of ProQuad demonstrated seroconversion rates and a magnitude of antibody response similar to those observed after administration of its individual components, M-M-R II and Varivax vaccines. The incidence of local side effects (pain/tenderness/soreness, erythema, swelling, ecchymosis and rash) and systemic adverse effects (fever, irritability, rash, upper respiratory infection, viral exanthema and diarrhea) is similar to or lower than that observed in component vaccines. ProQuad is a highly immunogenic combination vaccine with a good safety profile. The use of ProQuad combination vaccine will simplify immunization delivery by providing protection against more diseases with fewer injections and less pain, improve timely vaccination coverage and reduce the health-care costs for additional health visits. The ProQuad combination vaccine facilitates implementation of varicella vaccination into routine childhood immunization schedules and will help to protect children against these four potentially serious diseases.

Chickenpox↗

PubMed1986

Age of diphtheria, tetanus, and pertussis immunization of special care nursery graduates.

Diphtheria, tetanus, and pertussis (DTP) immunization data were collected on 103 special care nursery graduates in our neonatal follow-up clinic to determine whether DTP immunization schedules were significantly delayed relative to recommendations of the American Academy of Pediatrics (2, 4, and 6 months for DTP 1, 2, and 3, respectively). An inverse correlation was found between birth weight and immunization for first, second, and third DTP (r = 0.319, P less than .01; r = .205, P less than .05; and r = .236, P less than .05, respectively). We subsequently conducted a mail survey to determine the DTP immunization policy present in effect in 25 neonatal intensive care units in the United States and Canada. The survey indicates that procedural approaches remain markedly heterogeneous, and 10 of 25 (40%) units have no existing policy for implementation of DTP immunization. These data suggest that special care nursery populations are at potential risk for pertussis, which requires a conscious implementation of DTP immunization by the special care nursery, the follow-up clinic personnel, and the primary care physician.

Birth Weight↗

PubMed2000

Immunization coverage among predominantly Hispanic children, aged 2-3 years, in central Los Angeles.

PURPOSE: To assess the immunization status of young children in a predominantly Hispanic region in and around downtown Los Angeles, and factors associated with complete immunization by age 24 months. METHODS: The information was gathered in a two-stage cluster survey with probability proportionate to estimated size (PPS) sampling of 30 clusters at the first stage, and simple random sampling of a constant number of children at the second stage. Vaccination coverage was determined by a review of the home immunization (HI) card, or of clinic records. RESULTS: Of the 270 sampled children, 91.5% were Hispanic and 6.7% were Black. Home telephone numbers were not available in 24.8% of the homes, and 34.1% reported having no health insurance. Vaccination coverage was over 90% for the first three doses of Diphtheria, tetanus toxoids and pertussis/ diphtheria, tetanus toxoids and acellular pertussis vaccine (DTP/DTaP)/Diphtheria and tetanus toxoids vaccine (DT), first two doses of poliovirus (Polio) vaccine, first dose of measles, mumps and rubella (MMR) vaccine, and first two doses of hepatitis B (Hep B) vaccine. Yet, by age 24 months, only 72.2% of the children had received the combined series of 4:3:1 (i.e., four DTP/DTaP/DT, three Polio, one MMR). This was further reduced to 64.4% for the combined series of 4:3:1:3:3 (i.e., four DTP/DTaP/ DT, three Polio, one MMR, three Haemophilus influenzae type b (Hib), three Hep B). Factors associated with completed on-time vaccination were having an HI card available during the interview and being enrolled in Supplemental Nutrition Program for Women, Infants and Children (WIC). CONCLUSIONS: While vaccination levels for individual antigens were found to be high, more emphasis needs to be placed on getting preschool children vaccinated on-time according to the Recommended Childhood Immunization Schedule.

Child, Preschool↗

PubMed2005

Impact of the introduction of pneumococcal conjugate vaccine on immunization coverage among infants.

BACKGROUND: The introduction of pneumococcal conjugate vaccine (PCV) to the U.S. recommended childhood immunization schedule in the year 2000 added three injections to the number of vaccinations a child is expected to receive during the first year of life. Surveys have suggested that the addition of PCV has led some immunization providers to move other routine childhood vaccinations to later ages, which could increase the possibility of missing these vaccines. The purpose of this study was to evaluate whether introduction of PCV affected immunization coverage for recommended childhood vaccinations among 13-month olds in four large provider groups. METHODS: In this retrospective cohort study, we analyzed computerized data on vaccinations for 33,319 children in four large provider groups before and after the introduction of PCV. The primary outcome was whether the child was up to date for all non-PCV recommended vaccinations at 13 months of age. Logistic regression was used to evaluate the association between PCV introduction and the primary outcome. The secondary outcome was the number of days spent underimmunized by 13 months. The association between PCV introduction and the secondary outcome was evaluated using a two-part modelling approach using logistic and negative binomial regression. RESULTS: Overall, 93% of children were up-to-date at 13 months, and 70% received all non-PCV vaccinations without any delay. Among the entire study population, immunization coverage was maintained or slightly increased from the pre-PCV to post-PCV periods. After multivariate adjustment, children born after PCV entered routine use were less likely to be up-to-date at 13 months in one provider group (Group C: OR = 0.5; 95% CI: 0.3-0.8) and were less likely to have received all vaccine doses without any delay in two Groups (Group B: OR = 0.4, 95% CI: 0.3 - 0.6; Group C: OR = 0.5, 95% CI: 0.4-0.7). This represented 3% fewer children in Group C who were up-to-date and 14% (Group C) to 16% (Group B) fewer children who spent no time underimmunized at 13 months after PCV entered routine use compared to the pre-PCV baseline. Some disruptions in immunization delivery were also observed concurrent with temporary recommendations to suspend the birth dose of hepatitis B vaccine, preceding the introduction of PCV. CONCLUSION: These findings suggest that the introduction of PCV did not harm overall immunization coverage rates in populations with good access to primary care. However, we did observe some disruptions in the timely delivery of other vaccines coincident with the introduction of PCV and the suspension of the birth dose of hepatitis B vaccine. This study highlights the need for continued vigilance in coming years as the U.S. introduces new childhood vaccines and policies that may change the timing of existing vaccines.

Cohort Studies↗

PubMed1978

Simultaneous administration of live attenuated measles vaccine with DTP vaccine.

Live attenuated measles vaccine was administered to Cameroonian children 12 to 39 months of age alone or with either diphtheria-tetanus toxoids or diphtheria and tetanus toxoids and pertussis (DTP) vaccine. Among children who were initially seronegative for measles hemagglutination inhibition antibodies, seroconversion rates and postvaccination geometric mean titers were similar in all groups. Pertussis antigen in the DTP vaccine was judged to be potent by laboratory potency testing and serologic response in recipients of the vaccine. Thus, the two vaccines may be administered simultaneously without compromising their immunogenicity. These results allow greater flexibility in planning individual or mass immunization schedules.

Antibodies↗

PubMed1990

Efficacy of three doses of oral polio immunization beginning within the first four days of life.

A study was carried out to test the efficacy of oral polio immunization commencing in the newborn period. In Group A, 47 term newborn infants were given trivalent oral polio vaccine (TOPV) within the first four days, at one month and at two months. In Group B, 21 infants were given TOPV at 3, 4 and 5 months. The seroconversion rates for types 1, 2 and 3 were 87.2, 95.7 and 72.3%, respectively in Group A and 85.7, 95.2 and 66.7%, respectively in Group B after 3 doses of TOPV, the differences being insignificant. Oral polio immunization beginning in the newborn period was as effective as when commenced at 3 months of age. Before immunization, the number of babies with protective titers against polioviruses were significantly more in Group A as compared to Group B. Thus, the later onset of immunization schedule leaves more children susceptible to poliomyelitis during the first 3 months of life.

Humans↗

PubMed1997

Immunogenicity study of Haemophilus influenzae type B conjugate vaccine in Indian infants.

OBJECTIVE: To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC). DESIGN: Prospective multicenter study. SETTING: Pediatric Out Patient Department of general hospitals in Pune and Mumbai. SUBJECTS: 124 full term healthy infants brought for routine DPT/OPV immunization. METHODS: Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections. RESULTS: The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection. CONCLUSION: HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.

Antibodies, Bacterial↗

PubMed2003

Predictors of age-appropriate receipt of DTaP dose 4.

BACKGROUND: In the United States, the national childhood immunization schedule calls for children to receive four doses of DTaP (diphtheria and tetanus toxoids and acellular pertussis) vaccine administered at 2, 4, 6, and 15 to 18 months. Dose 4 of DTaP is among the most frequently missed vaccines for children who are not adequately immunized. METHODS: Using the 2001 National Immunization Survey, the effect of the timeliness of the first three DTaP doses was assessed on completion of the four-dose series by age 24 months and on time by age 12 to 18 months. RESULTS: Missing Dose 4 was more prevalent among children who received Dose 3 late (but <16 months) than among children who received Dose 3 on time (24% vs 10%). Similarly, receiving Dose 4 late (or not at all) was more prevalent among children who received Dose 3 late (but <9 months) (39% vs 22%). An invalid Dose 4 was administered to 4.6% of those with Dose 3 late but before 9 months and to 10.6% of those with no Dose 3 before 9 months, compared to 1.2% of those with Dose 3 on time. CONCLUSIONS: Physicians and staff can identify children at risk for missing the fourth DTaP dose or receiving it late by assessing timeliness of receipt of DTaP Dose 3 and implementing steps to ensure that at-risk children receive Dose 4 as recommended.

Diphtheria↗

PubMed2005

[Vaccination in premature infants: an issue many times forgotten].

Vaccine-preventable diseases may be serious and even life threatening in premature infants. Opportunities for immunization are frequently missed due to parental or healthcare personnel misconceptions on safety or immunogenicity of vaccines in these children. In addition, the impact of infectious diseases is frequently underestimated in preterms. There is no evidence of a higher incidence rate of vaccine associated adverse reactions in premature babies. For the majority of preterm infants vaccines provide protection against severe disease except for those extremely premature (less than 1500 grs) in whom the immune response may be less. Adherence to the EPI Vaccine Program is critical in this population with an immunization schedule similar to that of term infants, following chronological age. Premature follow-up programs should include additional vaccines not included in the EPI Program, such as conjugated pneumococcal vaccines and annual influenza inactivated vaccine. An additional strategy to protect preterms is the strict adherence to vaccination schedule among contacts including use of special vaccines in older children and adult contacts such as influenza and acellular pertussis vaccines.

Bacterial Vaccines↗

PubMed1999

Oral iodine supplementation does not reduce neutralizing antibody responses to oral poliovirus vaccine.

Iodine deficiency is a major cause of impaired mental development, goitre, and cretinism in many parts of the world. Because existing immunization programmes can be used to deliver oral iodized oil (OIO) to infants at risk, it was important to know whether OIO could adversely affect the antibody response to vaccines, such as trivalent oral poliovirus vaccine (OPV). A randomized, double-blind, placebo-controlled clinical trial was conducted in Subang, West Java, Indonesia, in which 617 eight-week-old infants received either OIO or a placebo (poppy-seed oil) during a routine visit for their first dose of OPV as part of the Expanded Programme on Immunization (EPI). The infants received two boosters of OPV at 4-week intervals after the first dose, and were followed up when 6 months old. Neutralizing antibody titres to poliovirus serotypes 1, 2, and 3 were compared in serum samples that were taken from 478 of these infants just before the first dose of OPV and at 6 months. It was found that oral iodized oil did not reduce the antibody responses to any of the three serotypes of OPV. These results indicate that oral iodine may safely be delivered to infants at the same time as oral poliovirus vaccine according to current EPI immunization schedules.

Analysis of Variance↗

PubMed1988

Immunization, practice records and the white paper.

The accuracy of all immunization records for a cohort of two to three year olds, registered with one general practice, was investigated. Information was obtained from practice notes, the practice computer, the district health authority records and the parents of those children whose records indicated they had outstanding immunizations. The combined results revealed a rate for completed immunization schedules of 72%, but the rate recorded by the district health authority was only 40%. All the records were defective because the systems for exchange of data were not functioning properly. The government's white paper on primary health care links practice income to performance, and immunization rate is one index of this. On the basis of the district health authority records, this practice would be wrongly penalized.

Child, Preschool↗

PubMed1995

The demand for childhood immunizations: results from the Baltimore Immunization Study.

In spite of the net social benefits of childhood vaccines, a substantial proportion of American children do not receive their full complement of immunizations by their second birthday. Designing policies and programs that increase the rate of completed immunizations in preschool children requires an understanding of the factors which contribute to the timely receipt of immunizations. In this paper, we estimate a model of demand for immunizations for preschool children. Our results suggest that household resources, the child's usual source of care, and other "convenience factors" significantly influence the successful completion of the immunization schedule.

Adult↗

PubMedDate not supplied

[Incidence of invasive pneumococcal disease in Cantabria, Spain, [1995-2001] and implications for the childhood inmunization schedule].

OBJECTIVE: To describe the incidence of invasive pneumococcal disease in Cantabria (Spain) between 1995 and 2001. METHOD: We reviewed the records of the Minimum Data Set (MDS) of public hospitals in Cantabria, discharges from private hospitals and the registry of diseases of mandatory reporting, as well as the microbiologic diagnoses and medical records of children discharged from the Pediatric Service of the Cantabria Hospital (the tertiary care hospital in our autonomous community). RESULTS: We obtained a meningitis incidence of 5.55, 5.03 and 0.76/100,000 in children < 2 years, > or = 2 and < 5 years, and > or = 5 years respectively, and an incidence of invasive disease of 11.11, 11.32 and 1.49/100,000 in the same age groups. CONCLUSIONS: The incidence of meningitis and invasive pneumococcal disease in Cantabria is low. We discuss factors that should be taken into account when introducing the pneumococcal conjugate vaccine in the childhood immunization schedule of Cantabria.

Humans↗

PubMed1999

[Value of vaccination data analysis at the district level].

This study aimed to demonstrate the importance of analysing local immunization data to improve performance of national prevention programmes. From the immunization registers kept in basic health centres, we identified 1271 children receiving their first vaccine at 3 months. Examination of the age at the subsequent vaccinations and time intervals between vaccinations showed that 81.9% had received all the vaccines required by the Ministry of Health but only 48.5% had received immunization meeting the requirements for age and time interval. The analysis also helped identify health centres with best performance (fewer children lost to follow-up and better implementation of immunization schedule) and those vaccinations needing the greatest attention from health professionals.

Age Factors↗

PubMed2006

National, state, and urban area vaccination coverage among children aged 19-35 months--United States, 2005.

The National Immunization Survey (NIS) provides vaccination coverage estimates among children aged 19-35 months for each of the 50 states and selected urban areas. Findings from the 2005 NIS include nationwide increases in coverage with >/=3 and >/=4 doses of pneumococcal conjugate vaccine (PCV) and continued high levels of coverage for the other recommended vaccines and vaccine series. In addition, no racial/ethnic disparities in coverage estimates were observed in the 4:3:1:3:3:1 vaccine series, the recommended series for children aged 19-35 months that includes DTP/DT/DTaP; poliovirus vaccine; measles, mumps, and rubella vaccine (MMR); Haemophilus influenzae type b vaccine; hepatitis B vaccine; and varicella vaccine. An important accomplishment indicated by the 2005 NIS data is the achievement of <50% coverage for the full series of PCV (>/=4 doses) and <80% coverage for >/=3 doses within 5 years after being added to the U.S.-recommended childhood immunization schedule in 2000. This occurred despite shortages of this vaccine during 2001-2004, which might have affected accessibility to PCV.

Child, Preschool↗