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Immunogenicity and Safety of a Liquid Hexavalent Vaccine in Indian Infants
Jugesh Chhatwal1, Sanjay Lalwani, Emmanuel Vidor
1Pediatrics Department, CMC and Hospital, Brown Road, Ludhiana, Punjab; #Pediatrics Department, Bharati Vidyapeeth University Medical College, Pune; India; and *Sanofi Pasteur, Lyon, France. Correspondence to: Emmanuel Vidor, Sanofi Pasteur, 2 avenue Pont Pasteur, 69367 Lyon, France. Emmanuel.Vidor@sanofipasteur.com.
Insights
This study shows the fully liquid hexavalent vaccine (DTaP-IPV-HB-PRP~T) is highly immunogenic and safe for Indian infants. The vaccine demonstrated excellent protection against six diseases, with good tolerability in the study population.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Infant immunization is crucial for preventing infectious diseases.
- Hexavalent vaccines offer a streamlined approach to protect against multiple pathogens with fewer injections.
- Evaluating vaccine efficacy and safety in diverse populations, such as India, is essential.
Purpose of the Study:
- To assess the immunogenicity and safety of a fully liquid hexavalent vaccine (DTaP-IPV-HB-PRP~T) in Indian infants.
- To determine the immune response to all six antigens included in the vaccine.
- To evaluate the safety profile, including solicited and unsolicited adverse events.
Main Methods:
- A Phase III, single-arm study was conducted in two tertiary care hospitals in India.
- 177 healthy infants received the hexavalent vaccine at 6, 10, and 14 weeks of age, alongside birth doses of Hepatitis B and Oral Polio Vaccine (OPV).
- Immune responses were measured one month after the third vaccine dose, and safety was monitored for solicited and unsolicited events.
Main Results:
- High seroprotection rates were observed: 100% for Hepatitis B, Haemophilus influenzae type b (PRP), Tetanus (T), and all three poliovirus types; 99.3% for diphtheria.
- Vaccine response rates for pertussis antigens were 93.8% for pertussis toxoid (PT) and 99.3% for filamentous hemagglutinin (FHA).
- The vaccine was well-tolerated, with solicited reactions reported in 37.9% (injection site) and 54.6% (systemic) of infants. Unsolicited events occurred in 20.3%, and serious adverse events were rare and unrelated to vaccination.
Conclusions:
- The fully liquid hexavalent DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in Indian infants when administered on a 6, 10, 14-week schedule.
- The vaccine was well-tolerated and demonstrated a favorable safety profile in this study population.
- This hexavalent vaccine represents a safe and effective immunization option for infants in India, contributing to comprehensive disease prevention.
Objective:
To evaluate the immunogenicity and safety of a fully liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV- HB-PRP~T) vaccine in Indian infants.
Design:
Phase III, single-arm study.
Setting:
Two tertiary care hospitals.
Participants:
177 healthy, 6-week-old infants.
Intervention:
All participants received hepatitis B vaccine and Oral polio vaccine (OPV) at birth and DTaP-IPV-HB-PRP~T at 6, 10, 14 weeks of age.
Main Outcome Measures:
Serum was analyzed for immune responses to all antigens 1 month post- 3rd dose; safety was assessed for 30 minutes post-vaccination, and for 7 days (solicited reactions) and 30 days (unsolicited events).
Results:
Seroprotection rates were 100% for anti-HB (>10 mIU/mL), anti-PRP (>0.15 ug/mL), anti-T (>0.01 IU/mL), anti-polio 1, 2, and 3 (>8 [1/dil]), and 99.3% for diphtheria (>0.01 IU/mL). For the pertussis antigens, vaccine response rate was 93.8% for anti-PT and 99.3% for anti-FHA. 37.9% and 54.6% of participants experienced at least one solicited injection site and systemic reaction, respectively, and 20.3% of participants experienced at least one unsolicited event (none of which was related to the vaccination). Four serious adverse events (including one death) were reported, but none was related to the vaccination.
Conclusion:
The fully liquid DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in infants in India when administered in a 6, 10, 14 week schedule along with HB and OPV administered at birth, and was well tolerated.
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