Maternal Tdap Immunization in Guatemala

NCT02301702 | Completed Phase 2

• 1 other identifier: IRB00072201
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they are fully vaccinated because maternal antibodies may cross the placenta and passively protect her infant. The proposed study is a randomized, blinded, controlled, vaccine trial of maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36 weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa. Enrolled women and their infants will be followed up until 7 months post-partum.

Conditions

Pertussis; Whooping Cough

Keywords

Maternal Immunization; Tdap; Td; Pertussis

Outcome Measures

Primary Outcomes (5)

• Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at birth (cord blood OR infant blood within 72 hours of birth), at 2 months of age, and 7 months of age

  Birth to 7 months of age

• Ratio of infant to mother pertussis antibody levels at the time of delivery

  Birth to 7 months of age

• Proportion of infants with at least a four-fold rise in serum antibody titer between 2 months and seven months of age (i.e., at four weeks after the 3rd dose of childhood DTwP)

  Birth to 7 months of age

• Maternal pertussis antibody GMC and 95% confidence intervals at baseline (pre-vaccination), within 72 hours after delivery, and seven months post-partum

  Pre-vaccination to 7 months post-partum

• Proportion of mothers sero-converting (serum pertussis antibody titer increase of ≥ 4-fold compared to pre-vaccination antibody levels) and 95% confidence intervals at the time of delivery (within 72 hours after delivery) and seven months post-partum

  Pre-vaccination to 7 months post-partum

Secondary Outcomes (9)

• Incidence of illnesses meeting the syndromic case definition (defined below); prematurity; pneumonia (per WHO Integrated Management of Childhood Illness [IMCI] classification)

  Birth to 7 months of age

• Birth weight and infant growth/anthropometric measurements (e.g., height and weight for age).

  Birth to 7 months of age

• Incidence of unsolicited non-serious (grades 1 & 2) adverse events 7 days post-delivery (for neonates)

  Birth to 7 months of age

• Infant growth/anthropometric measurements (e.g., height and weight z-scores at birth and 7 months of age)

  Birth to 7 months of age

• Incidence of serious (grades 3 & 4) adverse events through 7 months of age

  Birth to 7 months of age

Study Arms (2)

Tdap Vaccine

EXPERIMENTAL

Combination Tetnus Toxoid, Reduced Diptheria Toxoid and Acellular Pertusis (Tdap)

Biological: Tdap

Td Vaccine

ACTIVE COMPARATOR

Tetanus toxoid and reduced diphtheria toxoid vaccine (Td)

Biological: Td

Interventions

Tdap BIOLOGICAL

Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine

Also known as: Boostrix, Adacel

Tdap Vaccine

Td BIOLOGICAL

The tetanus toxoid and reduced diphtheria toxoid vaccine (Td) used for this study will be the same preparation used by the National Immunization Program of Guatemala

Td Vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant woman in late second or third trimester of pregnancy (i.e., after 27 weeks gestation),
• Between the ages of 18 and 40 years (inclusive),
• Intends to remain in the study area for at least seven months after delivery,
• Has access to a mobile phone (defined as a phone in the possession of the participant or another family member with whom she lives),
• Able to provide informed consent. If participant is illiterate, procedures to ensure full understanding of the research and consent process will be implemented according to international and federal guidelines.

You may not qualify if:

• History of fever or oral temperature ≥ 38.0 degree Celsius within 48 hours prior to vaccination (women can be re-evaluated at a subsequent visit),
• Received Tdap vaccine in the previous year,
• History of serious systemic disease, including but not limited to: Guillain-Barré syndrome; known HIV, hepatitis B, or hepatitis C infection; heart/lung disease; uncontrolled diabetes mellitus (including gestational diabetes); chronic liver/kidney disease; clinically significant neurological disorders. This information will be based on self-reporting and (where possible) will be confirmed by health facility medical records.
• High risk pregnancy, as identified by the Normas de Atención en Salud Integral, a guideline document published by the Ministry of Health, and also any previous complicated pregnancy or preterm delivery, spontaneous or medical abortion, or previous congenital anomaly,
• Received immunoglobulin or other blood product within the preceding 3 month (with the exception of Rhogam),
• History of allergy to any component of the vaccines (i.e. eggs, egg proteins, gelatin, formaldehyde, glutaraldehyde, polyethylene glycol p-isooctylphenyl ether, sucrose, aluminum hydroxide, polysorbate 80) or to latex,
• History of severe reaction (including hypersensitivity) after receiving any vaccine,
• History or evidence of immunosuppression (due to illness or treatment) or is on immunosuppressive therapy (includes long term use of steroids; use of high-dose inhaled steroids within past six months; with the exception of treatment with betamethasone or dexamethasone injections for the prevention of lung immaturity in the last trimester of pregnancy,
• In the opinion of the study team - it would be unsafe or unsuitable for the pregnant mother or her fetus to receive the vaccine or participate in the study.

Sponsors & Collaborators

• Emory University: lead
• Universidad del Valle, Guatemala: collaborator

Study Sites (1)

Universidad del Valle de Guatemala

Guatemala City, 01015, Guatemala

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

Boostrix; adacel

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Saad B. Omer, MBBS,MPH,PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health, Epidemiology, and Pediatrics

Study Record Dates

• First Submitted: November 22, 2014
• First Posted: November 26, 2014
• Study Start: July 1, 2016
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

GU (1)