Biomedical subjects

J A Englund

Publications and source records attributed to J A Englund.

At least 19 recordsLinked to original sources

PubMed2001

Maternal immunization with pneumococcal polysaccharide vaccine in the third trimester of gestation.

In a randomized, double blinded study, 23-valent pneumococcal polysaccharide vaccine (PSV) or conjugate Haemophilus influenzae type b (HbOC) vaccine was administered to 60 healthy women in the third trimester of gestation. Total IgG, IgG1, and IgG2 antibodies to pneumococcal serotypes 6B, 14, 19F and 23F were measured by ELISA in mothers prior to immunization, at delivery and 7 months after delivery, and in infants at birth (cord blood), 2 and 7 months after delivery. IgA was evaluated in breast milk at 2 and 7 months, and opsonophagocytic activity in cord blood. PSV was safe and immunogenic in pregnant women. Transplacental transmission of vaccine-specific antibodies was efficient. Maternal immunization with PSV resulted in significantly higher concentrations of pneumococcal antibodies in infants at birth and at 2 months of age, and greater functional opsonophagocytic activity of passively acquired IgG antibody.

Adult↗

PubMed2001

Vaccines in pregnancy.

The concept of maternal immunization to prevent infectious diseases during a period of increased vulnerability in the infant is supported by historical experience and carefully conducted studies of various viral and bacterial vaccines. Candidate vaccines should be minimally reactogenic, immunogenic, and safe. Health education and access to immunization should be a priority if maternal immunization is to succeed as a disease prevention strategy. The potential effect on the incidence of disease in the newborn and young infant can only increase as more candidate vaccines that could be administered during pregnancy become available. In the future, common infections and other, more dreaded diseases, such as herpes simplex virus infection, cytomegalovirus, and human immunodeficiency virus infection, could be prevented with this intervention. Further research on the safety and efficacy of maternal immunization must continue if the occurrence of serious infectious diseases in neonates and young infants is to be reduced.

Adult↗

PubMed2001

Diagnosis and epidemiology of community-acquired respiratory virus infections in the immunocompromised host.

Infections due to community-acquired respiratory viruses are important causes of morbidity and mortality among immunocompromised patients. Respiratory syncytial virus, influenza viruses, and parainfluenza viruses are the most frequent causes of serious lower respiratory tract infections in this patient population. Early diagnosis, often possible with the use of rapid detection assays, is essential for optimal management and prevention of the spread of these serious infections to other vulnerable patients.

Bone Marrow Transplantation↗

PubMed2001

Safety and antibody persistence following Haemophilus influenzae type b conjugate or pneumococcal polysaccharide vaccines given before pregnancy in women of childbearing age and their infants.

BACKGROUND: Immunization of healthy women before pregnancy is a potential approach to providing increased levels of maternal antibody to newborns to protect them from infections occurring during the perinatal period and first months of life. METHODS: Healthy nonpregnant Pima Indian women of childbearing age were randomized to receive one of two Haemophilus influenzae type b (Hib) conjugate vaccines [HbOC or Hib-meningococcal outer membrane protein complex (OMP)] or a 23-valent pneumococcal polysaccharide vaccine (PnPs). Infants received Hib-OMP vaccine at 2, 4 and 12 months of age. Vaccine safety and immunogenicity was evaluated in the women and their infants. RESULTS: Anti-polyribose ribitol phosphate antibody titers were significantly higher in women in both Hib conjugate vaccine groups than in the pneumococcal vaccine group throughout the 37-month observation period. Antibody responses to HbOC vaccine were significantly higher than those to Hib-OMP. A subsequent booster dose of each Hib conjugate vaccine induced reactions and antibody responses similar to those of the first dose. Infants born to mothers immunized with Hib vaccines compared with PnPs had significantly higher polyribose ribitol phosphate-specific IgG antibody titers at birth and 2 months of age but lower antibody responses to Hib-OMP at 6 months and similar titers before and after boosting with Hib-OMP at 1 year of age. By contrast women immunized with PnPs did not have significantly elevated concentrations of pneumococcal-specific antibody at delivery, and their infants had pneumococcal antibody titers similar to those of infants born to mothers who did not receive pneumococcal vaccine before pregnancy. CONCLUSION: Hib conjugate vaccine given to women before pregnancy significantly increased the proportion of infants who had protective Hib antibody levels at birth and 2 months of age.

Adolescent↗

PubMed2000

Passive immunization for the prevention of otitis media.

The safety and protective efficacy of exogenously-administered immunoglobulin for the prevention of otitis media has been demonstrated in the clinical trials of the human-derived polyclonal immune globulin used to prevent Haemophilus influenzae type b disease and respiratory syncytial virus infection in high risk neonates and young children. However, this form of therapy is expensive, difficult to administer due to the requirements of slow intravenous infusion or relatively large volumes given intramuscularly, and associated with side effects related to the volume and nature of the immunoglobulin preparation. In contrast, RSV-specific monoclonal antibody has not been as successful as human-derived immunoglobulin in preventing otitis media in high risk infants. The administration of monoclonal-antibody for the prevention of otitis media will be difficult, potentially due to the need for antibody to multiple epitopes of the viral and bacterial pathogens which could be targets. The use of maternal antibody to provide passive immunity to young infants at a time when they are most vulnerable to severe sequelae of infection can also be considered. We have studied maternal immunization using either a 23-valent pneumococcal polysaccharide vaccine or a conjugate H. influenzae type b (Hib) vaccine. Significant levels of maternally-derived Hib or pneumococcal antibody were transferred from the mother to the infant at the time of birth and persisting, for some antigens, through 2 months of age. The use of maternal immunization to prevent otitis media and other respiratory complications remains to be studied, but results of these small clinical trials indicate further clinical investigation is warranted.

Antibodies, Bacterial↗

PubMed2000

Treatment-mediated changes in human immunodeficiency virus (HIV) type 1 RNA and CD4 cell counts as predictors of weight growth failure, cognitive decline, and survival in HIV-infected children.

This meta-analysis of 5 large studies of the Pediatric AIDS Clinical Trials Group was undertaken to evaluate the predictive value of antiretroviral treatment-mediated changes in 3 markers of human immunodeficiency virus (HIV) type 1 disease progression-HIV-1 RNA level, CD4 cell count, and CD4 percentage-for weight growth failure, cognitive decline, and survival in HIV-infected children. Proportional hazards models were used to assess the prognostic value of the markers at baseline and after 24 weeks of treatment, with data from 1089 children. Among children receiving nucleoside with or without nonnucleoside reverse-transcriptase inhibitors, higher immunologic and lower virologic markers at baseline and after 24 weeks were significant independent predictors of survival, whereas virologic markers were significant predictors of weight growth and cognitive failure in children >1 year old. The finding of differential age effects on pediatric-specific clinical outcomes emphasizes the need for continued investigation of treatment effects in children.

Acquired Immunodeficiency Syndrome↗

PubMed2000

The CCR5Delta32 allele slows disease progression of human immunodeficiency virus-1-infected children receiving antiretroviral treatment.

The role of the CCR5Delta32 allele in human immunodeficiency virus (HIV)-1-related disease progression was analyzed for 457 antiretroviral-naïve children who had participated in the Pediatric AIDS Clinical Trials Group 152 study, which demonstrated that didanosine (ddI) or zidovudine + ddI treatments were superior to zidovudine alone. The CCR5Delta32 allele was detected at an overall frequency of 6.1% (28/457). At study entry, heterozygote children (wild type [wt]/Delta32) had higher baseline median CD4(+) counts/mm(3) than wt/wt children had (1035 vs. 835 cells/mm(3); P=. 043), higher mean weight-for-age Z scores (-0.15 vs. -0.84; P=.01), and a trend toward less cortical atrophy (P=.059). During antiretroviral treatment and study follow-up, there was a trend toward less disease progression and death among heterozygote children than among wt/wt children (P=.056; relative hazard, 0.28; 95% confidence interval, 0.07-1.13) independent of the antiretroviral treatment to which they were randomized.

Alleles↗

PubMed2000

A step ahead. Infant protection through maternal immunization.

The concept of maternal immunization to prevent infectious diseases during a period of increased vulnerability in infants is not new and is supported by historical experience and carefully conducted studies of various viral and bacterial vaccines. Candidate vaccines should be minimally reactogenic, immunogenic, and safe for maternal immunization to be considered as a disease prevention strategy. The possibilities increase as more potential candidate vaccines for use during pregnancy become available, including conjugate meningococcal vaccines, parainfluenza virus type 3 purified subunit vaccines, herpes simplex virus, cytomegalovirus, and HIV vaccines. Additional research on the safety and efficacy of maternal immunization must continue to effect the development of infectious diseases in neonates and infants.

Bacterial Vaccines↗

PubMed2000

Diminution of the anti-polyribosylribitol phosphate response to a combined diphtheria-tetanus-acellular pertussis/Haemophilus influenzae type b vaccine by concurrent inactivated poliovirus vaccination.

BACKGROUND: Prelicensure studies of Haemophilus influenzae type b vaccines (Hib) and diphtheria-tetanus-acellular pertussis vaccines (DTaP) were evaluated with concurrent oral poliovirus vaccine (OPV). However, inactivated poliovirus vaccine (IPV) is now recommended. A trial was conducted in which infants received a DTaP and Hib vaccine, separately (+) or combined (/), with either all OPV, all IPV or sequential IPV-OPV for the primary series of vaccinations. METHODS: In this protocol 567 infants were equally randomized to receive one of the following: Reference Arm A, DTaP + Hib + OPV; Treatment Arm B, DTaP/Hib + OPV; Treatment Arm C, DTaP/Hib + IPV at 2 and 4 months and OPV at 6 months; or Treatment Arm D, DTaP/Hib + IPV. antibodies against all administered antigens were measured at 7 months of age. Children with an antibody response to Hib (anti-polyribosylribitol phosphate (anti-PRP) <0.15 microg/ml had an antibody titer repeated after the toddler booster immunization. RESULTS: A significant diminution in the anti-PRP response was observed at 7 months of age in children given two or three doses of IPV concurrently with DTaP/Hib, compared with the groups given OPV. The geometric mean concentration of anti-PRP, percentage of children with > or = 0.15 microg/ml and percentage of children with > or = 1.0 microg/ ml, respectively, were: A, 4.4, 98%, 81%; B, 3.2, 94%, 78%; C, 1.3, 86%, 58% and D, 1.2, 84%, 53%. CONCLUSION: In this trial concurrent IPV appeared to interfere with the anti-PRP response to DTaP/Hib vaccine, suggesting that introduction of new vaccines may require evaluation of immune responses to all concurrently administered vaccines.

Adhesins, Bacterial↗

PubMed2000

Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four- to six-year-old children.

OBJECTIVE: To evaluate the safety and immunogenicity of 6 different acellular pertussis vaccines combined with diphtheria and tetanus toxoids (DTaP) and with 1 licensed whole-cell pertussis vaccine (DTwP) as a fifth dose in children who had previously received the same DTaP, a different DTaP, or DTwP as primary and fourth-dose vaccinations. METHODS: Healthy 4- to 6-year-old children were enrolled at 5 National Institute of Allergy and Infectious Diseases Vaccine Treatment and Evaluation Units to receive a fifth dose of a DTaP or DTwP vaccine. All had been randomly assigned to receive 3 primary doses of DTaP or DTwP at 2, 4, and 6 months and a fourth-dose booster at 15 to 20 months of age as part of earlier National Institutes of Health multicenter acellular pertussis vaccine trials. Parents recorded the occurrence and magnitude of fever, irritability, and injection site redness, swelling, and pain for 3 days after vaccination. Sera obtained before and 1 month after the booster vaccination were analyzed by enzyme-linked immunosorbent assay for antibody to pertussis toxin, filamentous hemagglutinin, fimbriae, pertactin, and diphtheria and tetanus toxoid. Safety and/or immunogenicity data are reported for 317 children who received DTaP and 10 children who received DTwP. RESULTS: Fever and moderate or severe irritability were uncommon following the fifth dose of DTaP vaccine and were generally less frequent than following the fourth dose. However, for the DTaP vaccine groups, redness, swelling, and pain increased in prevalence compared with the fourth dose. The time course and frequency of reactions following DTaP vaccination were generally similar in children who received the same DTaP, a different DTaP, or DTwP for previous doses in the 5- dose series. No significant differences among the DTaP vaccines were detected in the occurrence of reactions, but the statistical power to detect differences was limited by sample size. Significant increases in antibodies directed against the included antigens were observed for all DTaP vaccines in paired pre- and post-fifth dose sera. Post-fifth dose antibody concentrations differed significantly among the DTaP vaccines. Some children in the study showed an antibody response to an antigen not reported to be in the DTaP vaccine. CONCLUSION: All the studied DTaP vaccines performed similarly with regard to reactions, whether given as a fifth sequential dose of the same vaccine, a mix of different DTaP vaccines in the 5-dose sequence, or after 3 DTwP and 1 DTaP vaccinations. Large injection site reactions occurred more frequently after the fifth dose of DTaP than after the previous 4 doses. A fifth dose of all DTaP vaccines induced an antibody response to those antigens contained in the vaccine. No DTaP was consistently most or least reactogenic or immunogenic.

Antibodies, Bacterial↗

PubMed2000

Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines.

BACKGROUND: Diphtheria and tetanus toxoid combined with acellular pertussis (DTaP) vaccines are less reactogenic than diphtheria and tetanus toxoid combined with whole cell pertussis (DTwP) vaccines. However, local reactions increase in rate and severity with each successive DTaP dose, and swelling of the entire injected limb has been reported after booster doses. METHODS: We reviewed reports of swelling of the entire thigh or upper arm after the fourth and fifth dose, respectively, of DTaP vaccines administered in the National Institutes of Health multicenter comparative DTaP studies. Relationships were explored among reports of severe swelling, rates of other reactions, quantity of vaccine contents, and prevaccination and postvaccination antibody levels to pertussis toxin, tetanus toxin, and diphtheria toxin. RESULTS: Entire thigh swelling was an unsolicited reaction reported in 20 (2%) of the 1015 children who received 4 consecutive doses of the same DTaP vaccine. The reaction was associated with 9 of the 12 DTaP vaccines evaluated. Although there were no reports of swelling of the entire upper arm in 121 children given a fifth dose of the same DTaP, 4 (2.7%) of 146 recipients of 5 doses of a mixed schedule of DTaP vaccines experienced such swelling. Rates of other reactions were higher in children with entire thigh swelling than in those without. Of the children with entire thigh swelling, 60% had local pain, and 60% had erythema. All swelling subsided spontaneously without sequelae. There was a significant linear association between the rates of entire thigh swelling after dose 4 and diphtheria toxoid content in the DTaP products. Lesser degrees of swelling (>50 mm but less than entire limb) correlated with pertussis toxoid content after dose 4 and aluminum content after dose 5. No relationship was established between levels of serum antibody to diphtheria, tetanus, or pertussis toxin and rates of swelling of the whole thigh. CONCLUSIONS: Booster doses of DTaP vaccines can cause entire limb swelling, which is usually associated with redness and pain. Our data suggest that this extensive swelling reaction may be more common with vaccines containing high diphtheria toxoid content.

Antibodies, Bacterial↗

PubMed2000

Predicting HIV disease progression in children using measures of neuropsychological and neurological functioning. Pediatric AIDS clinical trials 152 study team.

BACKGROUND: Neuropsychological testing and 2 measures of neurological status, cortical atrophy, and motor dysfunction were assessed for their usefulness in predicting human immunodeficiency virus (HIV) disease progression in infants, children, and adolescents who participated in Pediatric AIDS Clinical Trials Group Protocol 152 (PACTG 152). METHODS: A cohort of 722 antiretroviral therapy-naive children with symptomatic HIV infection were assessed at study entry and at later intervals. Assessments included neurodevelopmental testing, neuroradiologic imaging, and neurological examination of motor function. CD4 cell count and plasma RNA viral load also were measured. RESULTS: Children with the lowest neuropsychological functioning (IQ < 70) at baseline had the highest risk for later HIV disease progression (56%), compared with those with borderline/low (IQ = 70-89) functioning (26%), or with average or above (IQ > 90) functioning (18%). This was also true of week 48 neuropsychological functioning. Motor dysfunction (especially reduced muscle mass) at entry also predicted disease progression. Furthermore, motor dysfunction and week 48 neuropsychological functioning provided predictive information beyond that obtainable from surrogate markers of HIV disease status (eg, CD4 count, HIV RNA level). Children with cortical atrophy also were at higher risk for later disease progression, but when CD4 count and RNA viral load were known, cortical atrophy information provided no additional predictive information. CONCLUSIONS: Measures of neuropsychological and motor function status provide unique information regarding pediatric HIV disease progression. As such, these findings have important implications for predicting long-term outcomes (eg, longevity) in pediatric patients.

AIDS Dementia Complex↗

PubMed1999

Respiratory system mechanics in patients receiving aerosolized ribavirin during mechanical ventilation for suspected respiratory syncytial viral infection.

Respiratory syncytial virus (RSV) is an important respiratory pathogen for infants. Aerosolized ribavirin (AR) has been used in mechanically ventilated (MV) patients with RSV bronchiolitis. The purpose of this study was to measure respiratory system mechanics (RSM) in pediatric patients requiring MV and receiving AR for suspected RSV. Patients were prospectively randomized to receive AR, either at a regular dose (RD) (6 g/300 mL over 18 hr/day) or a high dose (HD) (6 g/100 mL over 2 hr, three times a day). To measure changes in RSM, a passive exhalation technique was used before and after each dose of AR; time constant (tc) in s, resistance (Rrs) in cmH(2)O/mL/kg/s, and quasistatic compliance (Crs) in mL/cmH(2)O/kg were measured. Airway pressure and flow signals were obtained and analyzed using a pneumotachograph, a differential pressure transducer, and a computer interface. Statistical analysis was done by Mann-Whitney and Wilcoxon rank tests. Thirteen patients were enrolled: 5 patients in the HD group (mean age of 52 months), and 8 patients in the RD group (mean age of 10 months). Four and 5 patients were positive for RSV by ELISA in the HD and RD groups, respectively. The RSM in the HD group were: tc, 0.58 +/- 0.15 s and 0.55 +/- 0.20 s before and after AR, respectively; Rrs, 0.03 +/- 0. 03 cmH(2)0/mL/kg/s and 0.02 +/- 0.02 cmH(2)0/mL/kg/s, respectively; and Crs, 0.63 +/- 0.21 mL/cmH(2)O/kg and 0.70 +/- 0.13 mL/cmH(2)O/kg, respectively. In the RD group, the RSM were: tc, 0.37 +/- 0.12 s and 0.31 +/- 0.10 s before and after AR, respectively; Rrs, 0.03 +/- 0.02 cmH(2)0/mL/kg/s and 0.02 +/- 0.01 cmH(2)0/mL/kg/s, respectively (P < 0.05); and Crs, 0.46 +/- 0.20 mL/cmH(2)O/kg and 0.46 +/- 0.19 mL/cmH(2)O/kg, respectively. We conclude that the use of AR for bronchiolitis in infants and young children during mechanical ventilation does not worsen RSM.

Administration, Inhalation↗

PubMed1999

Virologic and immunologic response to nucleoside reverse-transcriptase inhibitor therapy among human immunodeficiency virus-infected infants and children.

Plasma human immunodeficiency virus RNA and CD4 lymphocyte response to nucleoside reverse-transcriptase therapy were evaluated in a large, comparative pediatric trial. Both baseline values and changes in the two laboratory markers over time correlated well with clinical outcome and possessed independent predictive value. In comparison of RNA reduction from baseline between the dideoxyinosine (ddI) and zidovudine+ddI therapeutic arms, marginal superiority of the combination arm was not correlated with an observed clinical benefit. Despite the size of this trial and the significantly higher rate of clinical end points in the zidovudine monotherapy group, attempts to establish surrogacy for plasma RNA were difficult. Nevertheless, plasma RNA and CD4 lymphocyte count together possess strong clinical predictive power and are valuable tools for both the clinician and the evaluation of new therapies.

Adolescent↗

PubMed1999

A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization.

The safety and immunogenicity of 5 acellular pertussis vaccines (ACVs) were compared in a multicenter, randomized, double-blind trial. A total of 481 healthy adults were given a single intramuscular booster dose of ACV or placebo. Three different dose levels were tested for 4 ACVs: full strength (the dose level proposed for infant immunization), one-third strength, and one-tenth strength. For 1 multicomponent vaccine, only the pertussis toxoid dose level varied. Minor injection site reactions were common and similar in frequency among vaccinated groups. Late-onset injection site reactions were seen in all ACV groups. Dose-related increases in mean antibody titers against vaccine antigens were seen after immunization with all ACVs. Antibody responses against antigens not known to be present in the vaccines were detected after immunization with 4/5 ACVs. Antibody levels fell significantly during the year after immunization. These data support evaluation of ACVs for broader use among adolescents and adults.

Adolescent↗

PubMed1999

Influenza A virus outbreak in a neonatal intensive care unit.

BACKGROUND: Nosocomial infections with influenza virus are rarely recognized in neonatal intensive care units (NICU). An outbreak of influenza A virus infection in the NICU of an urban county hospital during the 1997 to 1998 influenza season is reported. METHODS: Clinical and virologic data were recorded in all symptomatic NICU patients after influenza A infection was diagnosed in one infant in October, 1997. RESULTS: Influenza A/H3N2 was isolated from two of four symptomatic infants. The application of rapid diagnostic techniques for the characterization of influenza virus infection allowed the timely institution of basic infection control measures, limiting this outbreak. Resistance to amantadine was documented for the first time in this patient population by reverse transcription-PCR within 48 h of treatment in one case. CONCLUSIONS: Prevention by immunization is a priority in those caring for high risk NICU patients.

Cross Infection↗

PubMed1999

Neurologic, neurocognitive, and brain growth outcomes in human immunodeficiency virus-infected children receiving different nucleoside antiretroviral regimens. Pediatric AIDS Clinical Trials Group 152 Study Team.

OBJECTIVES: To compare the impact of three different nucleoside reverse transcriptase inhibitor regimens, zidovudine (ZDV) monotherapy, didanosine (ddI) monotherapy, and ZDV plus ddI combination therapy, on central nervous system (CNS) outcomes in symptomatic human immunodeficiency virus (HIV)-infected children. METHODS: Serial neurologic examinations, neurocognitive tests, and brain growth assessments (head circumference measurements and head computed tomography or magnetic resonance imaging studies) were performed in 831 infants and children who participated in a randomized double-blind clinical trial of nucleoside reverse transcriptase inhibitors. The Pediatric AIDS Clinical Trials Group study 152 conducted between 1991 and 1995 enrolled antiretroviral therapy-naive children. Subjects were stratified by age (3 to <30 months of age or 30 months to 18 years of age) and randomized in equal proportions to the three treatment groups. RESULTS: Combination ZDV and ddI therapy was superior to either ZDV or ddI monotherapy for most of the CNS outcomes evaluated. Treatment differences were observed within both age strata. ZDV monotherapy showed a modest statistically significant improvement in cognitive performance compared with ddI monotherapy during the initial 24 weeks, but for subsequent protection against CNS deterioration no clear difference was observed between the two monotherapy arms. CONCLUSIONS: Combination therapy with ZDV and ddI was more effective than either of the two monotherapies against CNS manifestations of human immunodeficiency virus disease. The results of this study did not indicate a long-term beneficial effect for ZDV monotherapy compared with ddI monotherapy.

Adolescent↗

PubMed1999

Prevention strategies for respiratory syncytial virus: passive and active immunization.

Prevention of respiratory syncytial virus (RSV) disease may ultimately be possible with active immunization, although no vaccine is currently available. Formalin-inactivated RSV vaccine caused serious disease in some recipients re-exposed to RSV, which slowed vaccine development. Current RSV vaccine candidates include RSV fusion protein vaccines, chimeric fusion protein-glycoprotein vaccines, and various live, attenuated RSV vaccines. RSV vaccines may be problematic in very young infants and newborns because of the relatively poor immunogenicity of most vaccine candidates to date. Passive immunization with human polyclonal intravenous immune globulin and humanized monoclonal antibody directed against the conserved fusion protein of RSV prevents severe RSV disease, although not necessarily viral infection. The humanized RSV monoclonal antibody is licensed for use in premature infants and infants with bronchopulmonary dysplasia and is being evaluated in infants with cardiac disease. Another innovative approach to prevent RSV disease in young infants is maternal immunization with a vaccine such as the purified fusion protein vaccine. Such a vaccine could stimulate antibody response to RSV surface glycoproteins and potentially prevent RSV disease in the mother, while maternal antibodies produced could be passively transmitted across the placenta to the infant. A pilot study in postpartum women demonstrated immunogenicity with no significant adverse reactions.

Antibodies, Monoclonal↗