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Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As
Sedigheh Rafiei Tabatabaei1, Abdollah Karimi1, Seyed Mohsen Zahraei2
1Pediatric Infections Research Center (PIRC), Research Institute for Children's Health (RICH), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Pentavac and Shan 5 pentavalent vaccines show similar immunogenicity, with Pentavac offering better pertussis protection than Pentabio. All vaccines demonstrated comparable safety profiles in infants.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Pentavalent vaccines are crucial for infant immunization programs.
- Pentavac, a pentavalent vaccine, was introduced into Iran's National Immunization Plan in 2014.
- Comparison of available pentavalent vaccines is essential for informed public health decisions.
Purpose of the Study:
- To evaluate and compare the immunogenicity and safety of Pentavac against Pentabio and Shan 5 pentavalent vaccines.
- To assess antibody titers against diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B antigens.
- To document and compare adverse events following vaccination for each vaccine brand.
Main Methods:
- A randomized, phase III clinical study involving 900 infants.
- Infants received one of three pentavalent vaccines (Pentavac, Pentabio, or Shan 5) at 2, 4, and 6 months of age.
- Antibody titers were measured pre-vaccination and one month post-vaccination; adverse events were recorded.
Main Results:
- All vaccines induced similar immunogenicity against diphtheria, tetanus, Haemophilus influenzae B, and hepatitis B.
- Shan 5 showed the highest pertussis immunogenicity, while Pentabio was significantly lower (P<0.001).
- Local adverse events varied significantly between vaccine brands (P<0.001), but systemic adverse events were largely similar (P>0.05).
Conclusions:
- Pentavac and Shan 5 exhibit comparable immunogenicity, with Pentavac demonstrating superior pertussis immunogenicity compared to Pentabio.
- Pentavac and Pentabio share a similar safety profile.
- The study provides valuable data for selecting pentavalent vaccines in national immunization programs.
Background:
The pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014.
Objective:
To compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.).
Design:
Randomized, phase III study.
Participants:
900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age.
Intervention:
Infants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups.
Outcomes:
The antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary.
Results:
All vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05).
Conclusions:
Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.
