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Immunogenicity and Safety of Monovalent Acellular Pertussis Vaccine at Birth: A Randomized Clinical Trial
Nicholas Wood1,2,3, Terry Nolan4,5, Helen Marshall6,7
1National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Westmead, New South Wales, Australia.
Insights
A birth dose of the acellular pertussis (aP) vaccine given with hepatitis B vaccine (HBV) is safe and immunogenic in newborns. This approach offers protection for infants whose mothers did not receive the Tdap vaccine during pregnancy.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Severe pertussis in infants poses a significant health risk.
- Maternal vaccination is a strategy to protect newborns, but an alternative is needed.
- Infant vaccination at birth requires data on immunogenicity and safety.
Purpose of the Study:
- To evaluate the immunogenicity and safety of a birth dose of monovalent acellular pertussis (aP) vaccine.
- To compare infant IgG antibody responses to vaccine antigens.
- To assess responses in infants receiving aP vaccine plus hepatitis B vaccine (HBV) versus HBV alone.
Main Methods:
- A randomized clinical trial involving 440 healthy term infants in Australia.
- Infants received HBV at birth, randomized to receive aP vaccine or not.
- Infants received DTaP, Hib, HBV, polio, and pneumococcal vaccines at 6, 16, and 24 weeks.
Main Results:
- At 10 weeks, 93.2% of infants receiving the aP birth dose had detectable pertussis antibodies versus 50.8% in the control group (P < .001).
- Infants receiving the aP birth dose showed a 4-fold higher geometric mean concentration of pertussis toxin IgG.
- Adverse events were similar between groups; infants receiving the aP birth dose had lower antibody concentrations for other antigens at 32 weeks.
Conclusions:
- The monovalent aP vaccine is immunogenic and safe in neonates.
- A birth dose of aP vaccine is a valuable option for newborns whose mothers did not receive Tdap vaccine antenatally.
- Further research and licensure are needed for this vaccination strategy.
Importance:
An alternative option to maternal vaccination to prevent severe pertussis in infants is vaccination at birth. Data are needed on the immunogenicity and safety of a birth dose of monovalent acellular pertussis (aP) vaccine.
Objective:
To compare IgG antibody responses to vaccine antigens at 6, 10, 24, and 32 weeks of age between newborn infants receiving the aP vaccine and hepatitis B vaccine (HBV) or HBV alone.
Design, Setting, And Participants:
A randomized clinical trial was conducted at 4 sites in Australia (Sydney, Melbourne, Adelaide, and Perth) between June 11, 2010, and March 14, 2013, among 440 healthy term (>36 weeks' gestation) infants aged less than 5 days at recruitment. Statistical analysis was performed from March 1, 2015, to June 2, 2016.
Intervention:
Newborns received HBV and, after stratification by maternal receipt of adult-formulated aP-containing vaccine (tetanus toxoid, reduced diphtheria toxoid, and pertussis antigen content [Tdap]) prior to pregnancy, were block randomized to receive the aP vaccine (without diphtheria or tetanus) within 5 days of birth or not. At 6, 16, and 24 weeks, infants received a hexavalent vaccine with pediatric-formulated diphtheria, tetanus and pertussis antigens (DTaP), Haemophilus influenzae type b (Hib), HBV, and polio vaccine, as well as the 10-valent pneumococcal conjugate vaccine.
Main Outcomes And Measures:
Detectable (>5 enzyme-linked immunosorbent assay units per milliliter) and geometric mean concentrations of IgG antibody to pertussis toxin (PT), pertactin, and filamentous hemagglutinin at 6, 10, and 24 weeks stratified by maternal Tdap history, and antibody at 32 weeks to HBV, Hib, polio, diphtheria, tetanus, and pneumococcal serotypes. The primary outcome was detectable IgG to both PT and pertactin at 10 weeks.
Results:
A total of 440 infants (207 girls and 233 boys; median gestation, 39.2 weeks) were randomized to receive the aP vaccine plus HBV (n = 221) or HBV only (control group; n = 219). At 10 weeks, 192 of 206 infants who received the aP vaccine (93.2%) had detectable antibodies to both PT and pertactin vs 98 of 193 infants in the control group (50.8%) (P < .001), with the geometric mean concentration for PT IgG 4-fold higher among the group that received the aP vaccine. At age 32 weeks, all infants (n = 181 with sera available for testing) who received the aP vaccine at birth had detectable PT IgG and significantly lower IgG geometric mean concentrations for Hib, hepatitis B, diphtheria, and tetanus antibodies. Local and systemic adverse events were similar between both groups at all time points.
Conclusions And Relevance:
The monovalent aP vaccine is immunogenic and safe in neonates and, if licensed and available, would be valuable for newborns whose mothers did not receive the Tdap vaccine during pregnancy.
Trial Registration:
http://anzctr.org.au Identifier: ACTRN12609000905268.
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