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Immunogenicity of a five-component acellular pertussis vaccine in infants and young children
S A Halperin1, L Barreto, B Friesen
1Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia.
Insights
This study found that a five-component acellular pertussis vaccine is safe and effective in young children. The inclusion of a 69-kd membrane protein did not increase side effects or impact the immune response to other vaccine components.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- Whole-cell pertussis vaccines have been associated with adverse reactions.
- Acellular pertussis vaccines offer a potentially safer alternative.
- Evaluating novel components in acellular vaccines is crucial for improving efficacy and safety.
Purpose of the Study:
- To compare the safety and immunogenicity of an acellular pertussis vaccine with and without a 69-kd membrane protein.
- To assess the vaccine's performance when combined with diphtheria and tetanus toxoids.
- To evaluate the vaccine in different age groups of children previously vaccinated with whole-cell pertussis vaccine.
Main Methods:
- Three groups of children (17-18 months and 4-6 years) received different formulations of the acellular pertussis vaccine, with or without the 69-kd protein, and with or without diphtheria and tetanus toxoids.
- Vaccine administration included randomized, double-blind, and open-enrollment designs.
- Reactogenicity was monitored through parental reports and structured interviews; immunogenicity was assessed by measuring antibody responses to vaccine antigens before and after immunization.
Main Results:
- No severe adverse reactions were reported across all vaccine groups.
- Systemic and local reactions were observed, but no significant differences were detected between vaccine formulations.
- The inclusion of the 69-kd membrane protein did not increase reactogenicity or negatively affect the antibody response to other antigens.
- All vaccine formulations elicited a robust antibody response to all included antigens.
Conclusions:
- The five-component acellular pertussis vaccine is safe and immunogenic in children aged 17-18 months and 4-6 years.
- The 69-kd membrane protein is immunogenic and can be safely included in the acellular pertussis vaccine formulation.
- This vaccine represents a safe and effective option for pertussis immunization.
Objective:
To compare the reactogenicity and immunogenicity of an acellular vaccine containing pertussis toxoid, filamentous hemagglutinin, and fimbriae 2 and 3, with and without the 69-kd membrane protein, alone or combined with diphtheria and tetanus toxoids.
Participants And Setting:
One hundred thirty-seven 17- to 18-month-old and 22 4- to 6-year-old children who had received three or four previous doses of whole-cell vaccine, respectively, were recruited from public health immunization clinics.
Design And Interventions:
Three groups of children were sequentially enrolled in the study to receive the acellular pertussis vaccine with or without a 69-kd protein (CP4 or CP5, 17- to 18-month-old children), the two vaccines combined with diphtheria and tetanus toxoids (CP4DT or CP5DT, 17- to 18-month-old children), or the CP5DT vaccine (4- to 6-year-old children). Children were assigned to the first two groups in a randomized and double-blind fashion; the last group was formed by open enrollment. Data regarding adverse reactions were recorded by the parents and collected via a structured interview administered seven times, five times during the first 72 hours. Serum samples were obtained before and 1 month after the immunization, and antibodies against each constituent of the vaccine were measured.
Results:
A systemic adverse reaction was reported in 40% to 65.7% of 17- to 18-month-old and 38.1% of 4- to 6-year-old children; no severe reactions occurred. A local reaction was reported in 8.6% to 29.4% and 71.4% of children, respectively. No differences were detected between respectively. No differences were detected between vaccines; inclusion of the 69-kd membrane protein did not increase reactogenicity. All vaccines elicited an antibody response to all antigens contained in the formulation.
Conclusions:
The five-component acellular pertussis vaccine (Connaught Laboratories Ltd, Willowdale, Ontario) is safe and immunogenic in 17- to 18-month-old and 4- to 6-year-old children. The 69-kd protein was immunogenic, and its inclusion neither increased side effects associated with the vaccine nor adversely affected the antibody response to the other components.