Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445743
• Other study ID #: EN11-009
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2011
• Last updated: February 12, 2014
• Start date: September 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Regional Materno Infantil de alta especialidad, Secretaria de Salud de Nuevo Leon	Guadalupe	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No