Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

February 12, 2014 updated by: Jose M. Ramirez-Aranda, Hospital Universitario Dr. Jose E. Gonzalez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Guadalupe, Nuevo Leon, Mexico, 66000
        • Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biological/Vaccine: Tdap Vaccine
Biological: Tdap Intervention women will receive a blinded dose of Tdap vaccine (ADACEL)
Biological: Biological/Vaccine: Tdap Vaccine
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.
Other Names:
  • ADACEL
PLACEBO_COMPARATOR: Placebo Comparator: Physiologic Saline solution
Administration of Tdap vaccine or placebo as a single 0.5 mL of Saline (0.9% NaCl) solution
Biological: Biological/Vaccine: Tdap Vaccine
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.
Other Names:
  • ADACEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elevation of specific pertussis antibody levels in children of women who were administered the immunization
Time Frame: 18 months
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
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Jose M Ramirez, MD; PhD, Proffesor of Family Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (ESTIMATE)

October 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN11-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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