PertussisPhase 2NCT02301702
Maternal Tdap Immunization in Guatemala
A Phase 2 study testing Tdap and Td in people with Pertussis and Whooping Cough, run by Emory University at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Whooping Cough
- What is being tested?
- Tdap and Td
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteGuatemala
- Study dates
- Jul 2016to 13 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tdap in Pregnancy to Prevent Infant Pertussis
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.
Read the detailed description
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 de Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa.
All healthy pregnant women between the ages of 18 and 40 years (inclusive) at 27 weeks gestation or later who are in the study areas will be eligible to participate in this study unless they meet one or more of the exclusion criteria. Pregnant women at <27 weeks gestation will be pre-screened and provided information about the study to encourage them to enroll later in their pregnancy. Women who are eligible will be enrolled after obtaining informed consent, and then they will be randomized to receive Tdap vaccine or Td vaccine. Enrolled women and their infants will be followed up until 7 months postpartum.
To address the primary objective, serum specimens will be collected from mothers prior to receiving the study product (Tdap or Td), within 72 hours after delivery and at 7 months post-partum. Moreover, infants specimens will be collected at delivery (cord blood or infant blood within 72 hours of birth), at 2 months of age (prior to the first dose of the routine childhood DTwP series), and at 7 months of age (approximately 4 weeks after the third dose of the routine DTwP series).
Infants will be given all three doses of the pentavalent vaccine which includes DTwP vaccine at 2, 4 and 6 months (routine childhood immunizations) as recommended by the immunization schedule of Guatemala's National Immunization Program.
Adverse events and serious adverse events will also be monitored.
- Conditions
- Pertussis, Whooping Cough
- Being tested
- Tdap, Td
- Keywords
- Maternal Immunization, Tdap, Td, Pertussis
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TdapBiological
Also called Boostrix, Adacel
Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
TdBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Tdap Vaccine | Experimental | Combination Tetnus Toxoid, Reduced Diptheria Toxoid and Acellular Pertusis (Tdap) Receives: Biological: Tdap |
| Td Vaccine | Active comparator | Tetanus toxoid and reduced diphtheria toxoid vaccine (Td) Receives: Biological: Td |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Birth to 7 months of age
Ratio of infant to mother pertussis antibody levels at the time of delivery
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Birth to 7 months of age
Birth weight and infant growth/anthropometric measurements (e.g., height and weight for age).
Measured: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1 & 2) adverse events 7 days post-delivery (for neonates)
Measured: Birth to 7 months of age
Infant growth/anthropometric measurements (e.g., height and weight z-scores at birth and 7 months of age)
Measured: Birth to 7 months of age
Incidence of serious (grades 3 & 4) adverse events through 7 months of age
Measured: Birth to 7 months of age
Laboratory (real-time PCR) confirmed pertussis infection in infants younger than 6 months of age
Measured: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1&2) AEs 28 days post vaccination
Measured: Pre-vaccination to 7 months post-partum
Incidence of serious (grades 3 & 4) adverse events through 7 months post-partum
Measured: Pre-vaccination to 7 months post-partum
Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at 19 months after delivery
Measured: Pre-vaccination to 19 mo post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJul 2016
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Valle, Guatemala
- Responsible party
- Principal investigator, Saad B. Omer, MBBS, MPH, PhD, Emory University
- Investigators
- Saad B. Omer, MBBS,MPH,PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301702
- Sponsor's protocol ID
- IRB00072201
- Status last verified
- Oct 2019
- First submitted
- 22 Nov 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tdap in Pregnancy to Prevent Infant Pertussis
- ClinicalTrials.gov ID
- NCT02301702
- Acronym / sponsor ID
- IRB00072201
- Conditions
- Pertussis, Whooping Cough
- Keywords
- Maternal Immunization, Tdap, Td, Pertussis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Universidad del Valle, Guatemala
- Study start
- Jul 2016
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 de Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan Ostuncalco and Concepción Chiquirichapa.
All healthy pregnant women between the ages of 18 and 40 years (inclusive) at 27 weeks gestation or later who are in the study areas will be eligible to participate in this study unless they meet one or more of the exclusion criteria. Pregnant women at <27 weeks gestation will be pre-screened and provided information about the study to encourage them to enroll later in their pregnancy. Women who are eligible will be enrolled after obtaining informed consent, and then they will be randomized to receive Tdap vaccine or Td vaccine. Enrolled women and their infants will be followed up until 7 months postpartum.
To address the primary objective, serum specimens will be collected from mothers prior to receiving the study product (Tdap or Td), within 72 hours after delivery and at 7 months post-partum. Moreover, infants specimens will be collected at delivery (cord blood or infant blood within 72 hours of birth), at 2 months of age (prior to the first dose of the routine childhood DTwP series), and at 7 months of age (approximately 4 weeks after the third dose of the routine DTwP series).
Infants will be given all three doses of the pentavalent vaccine which includes DTwP vaccine at 2, 4 and 6 months (routine childhood immunizations) as recommended by the immunization schedule of Guatemala's National Immunization Program.
Adverse events and serious adverse events will also be monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tdap Vaccine | Experimental | Biological: TdapCombination Tetnus Toxoid, Reduced Diptheria Toxoid and Acellular Pertusis (Tdap) |
| Td Vaccine | Active comparator | Biological: TdTetanus toxoid and reduced diphtheria toxoid vaccine (Td) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TdapAlso: Boostrix, AdacelCommercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine | Biological | Tdap Vaccine |
| TdThe 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 | Biological | Td Vaccine |
Primary outcome
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
Time frame: Birth to 7 months of age
Ratio of infant to mother pertussis antibody levels at the time of delivery
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Pre-vaccination to 7 months post-partum
9 secondary outcomes
Incidence of illnesses meeting the syndromic case definition (defined below); prematurity; pneumonia (per WHO Integrated Management of Childhood Illness [IMCI] classification)
Time frame: Birth to 7 months of age
Birth weight and infant growth/anthropometric measurements (e.g., height and weight for age).
Time frame: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1 & 2) adverse events 7 days post-delivery (for neonates)
Time frame: Birth to 7 months of age
Infant growth/anthropometric measurements (e.g., height and weight z-scores at birth and 7 months of age)
Time frame: Birth to 7 months of age
Incidence of serious (grades 3 & 4) adverse events through 7 months of age
Time frame: Birth to 7 months of age
Laboratory (real-time PCR) confirmed pertussis infection in infants younger than 6 months of age
Time frame: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1&2) AEs 28 days post vaccination
Time frame: Pre-vaccination to 7 months post-partum
Incidence of serious (grades 3 & 4) adverse events through 7 months post-partum
Time frame: Pre-vaccination to 7 months post-partum
Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at 19 months after delivery
Time frame: Pre-vaccination to 19 mo post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad B. Omer, MBBS,MPH,PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tdap and Td in people with Pertussis and Whooping Cough, run by Emory University at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Birth to 7 months of age). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.