Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

Study Overview
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Brief Summary
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That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine. The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.

Detailed Description
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Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State. The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel. For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age. Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2). Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.

Official Title
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Immunogenicity and Safety of an Acellular DPT Vaccine in Pregnant Women in Nuevo Leon, Mexico

Conditions
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Pregnancy

Intervention / Treatment
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* Biological: Biological/Vaccine: Tdap Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 38 years Pregnancy between 22 and 32 weeks of gestation Covered by Ministry of Health medical security Definitive residency in Guadalupe and Benito Juarez cities Pregnancy termination in the study's hospital. At low risk for complication as determined by the obstetrical risk assessment form (ORAF) Second trimester or later ultrasound with no significant abnormalities Intend to be available for follow up visits and phone calls access through 6 months following delivery Willing to give written informed consent Exclusion criteria: Serious mental illness. (Schizophrenia, psychosis, major depression). Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on. Current smoking or use of drugs. Receipt of tetanus-diphtheria toxoid immunization within the past 2 years. Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological/Vaccine: Tdap Vaccine<br>Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL) | Biological: Biological/Vaccine: Tdap Vaccine<br>* Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.<br>* Other names: ADACEL;|
| Placebo Comparator: Placebo Comparator: Physiologic Saline solution<br>Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution | Biological: Biological/Vaccine: Tdap Vaccine<br>* Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.<br>* Other names: ADACEL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elevation of specific pertussis antibody levels in children of women who were administered the immunization | Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non interference of acellular vaccine in children | To demonstrate the acellular pertussis immunization non interference in the effective development of pertussis antibodies in children at 2, 4, and 6 months of age. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tdap Vaccine, Pregnant woman, Pertussis