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Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

This study is currently recruiting participants.
Verified April 2013 by Hospital Universitario Dr. Jose E. Gonzalez
Sponsor:
Information provided by (Responsible Party):
Jose M. Ramirez-Aranda, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01445743
First received: September 23, 2011
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy
 Biological: Biological/Vaccine: Tdap Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Acellular DPT Vaccine in Pregnant Women in Nuevo Leon, Mexico

Resource links provided by NLM:

MedlinePlus related topics: Whooping Cough
U.S. FDA Resources

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Elevation of specific pertussis antibody levels in children of women who were administered the immunization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Elevation of at least three antibodies against either pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), or filamentous hemagglutinin (FHA).


Secondary Outcome Measures:
  • Non interference of acellular vaccine in children [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 204
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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 Name: ADACEL
Placebo Comparator: Placebo Comparator: Physiologic Saline solution

Administration of Tdap vaccine or placebo as a single 0.5 mL intramuscular injection into the deltoid in 102 pregnant randomly assigned women.

Placebo comprises in 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 Name: ADACEL

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445743

Contacts
Contact: Jose M Ramirez, MD, PhD 8183172246 sersabe2010@gmail.com

Locations
Mexico
Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon Recruiting
Guadalupe, Nuevo Leon, Mexico, 66000
Contact: Jose M Ramirez, MD, PhD     8183172246     sersabe2010@gmail.com    
Principal Investigator: Jose M Ramirez, MD, PhD            
Sub-Investigator: Jesus Z Villarreal, MD            
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: Jose M Ramirez, MD; PhD Proffesor of Family Medicine
  More Information

No publications provided

Responsible Party: Jose M. Ramirez-Aranda, Professor, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01445743     History of Changes
Other Study ID Numbers: EN11-009
Study First Received: September 23, 2011
Last Updated: April 10, 2013
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Tdap Vaccine
Pregnant woman
Pertussis

ClinicalTrials.gov processed this record on May 19, 2013