Education + Vaccination for Tdap Acceptance During Pregnancy

(ITAPP Trial)

Overseen By Adam Lewkowitz, MD/MPHS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Latex allergy, Lethal fetal anomaly

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care. The main question\[s\] it aims to answer are: * To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients. * To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza. Participants will receive direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery with or without the option to receive Tdap at their convenience at the WIH obstetric care clinic. If there is a comparison group: Researchers will compare "Upfront Education" and "Upfront Education and Vaccination Administration" to "Usual care" to see if education and/or the offer for vaccination in the office increases Tdap vaccine acceptance for non-birthing partners.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on vaccination education and administration, so it's unlikely that your current medications will be affected.

What data supports the effectiveness of the Tdap vaccine during pregnancy?

Research shows that the Tdap vaccine given during pregnancy is effective at preventing pertussis (whooping cough) in infants less than 2 months old, which helps protect newborns from this serious infection. ^{1 2 3 4 5}

Is the Tdap vaccine safe for use during pregnancy?

The Tdap vaccine is generally safe for use during pregnancy. Studies have shown that it is well tolerated by pregnant women and does not lead to pregnancy, postpartum, or neonatal complications. Common side effects are mild, such as pain at the injection site, and no unexpected adverse events have been reported. ^{6 7 8 9 10}

How is the Tdap vaccine unique for pregnant women?

The Tdap vaccine is unique for pregnant women because it is specifically recommended during each pregnancy to protect newborns from pertussis (whooping cough), which is a serious illness for infants. This approach is different from other vaccines as it focuses on providing immunity to the baby through the mother before birth. ^{2 11 12 13 14}

Research Team

Laurie Griffin, MD/PhD

Principal Investigator

Women and Infants Hospital

Eligibility Criteria

This trial is for non-birthing partners of pregnant patients aged 19-50, receiving prenatal care at OGCC. They must not have had the adult Tdap vaccine or booster in the last 10 years or be unsure if they did. Participants need to understand English or Spanish.

Inclusion Criteria

I haven't had or am unsure if I've had the Tdap vaccine in the last 10 years.

Partners of pregnant patients who are receiving their prenatal care at the OGCC

I can speak and understand either English or Spanish.

Exclusion Criteria

I am allergic to latex and cannot receive the state's Tdap vaccine.

Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Enrollment

Direct verbal and written education on cocooning and recommendation for partner Tdap vaccination prior to delivery

During pregnancy

1 visit (in-person)

Vaccination Administration

Participants receive the option to receive Tdap vaccination at their convenience at the WIH obstetric care clinic

During pregnancy

Follow-up

Participants are monitored for Tdap and dual vaccination rates during pregnancy through 1 week postpartum

1 week postpartum

Treatment Details

Interventions

• Tdap Vaccine

Trial Overview The study tests whether providing education on Tdap vaccination and offering vaccines directly at an obstetric clinic increases uptake among non-birthing partners compared to standard care. It also explores willingness to receive dual Tdap and influenza vaccinations.

Participant Groups

Group I: Upfront Education and Vaccination Administration: Experimental Treatment 2 Interventions

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery plus the option to receive Tdap at their convenience at the WIH obstetric care clinic.

Group II: Upfront Education Only Experimental Treatment 1 Intervention

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery

Group III: Usual Care Active Control 1 Intervention

No up-front education, routine counseling as per their primary provider's standard practice, and written education on cocooning and recommendation for partner Tdap vaccination provided upon completion of the postpartum survey

Tdap Vaccine is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Approved in Canada as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Approved in European Union as Tdap Vaccine for:

• Pertussis prevention in newborns
• Tetanus prevention
• Diphtheria prevention

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Findings from Research

The GSK Pregnancy Registry collected data on 1517 pregnancy reports involving the Boostrix Tdap vaccine, showing that the majority of infants born to vaccinated women were healthy and without birth defects, indicating a favorable safety profile.

Both the US and international data suggest that exposure to the Boostrix or Boostrix-IPV vaccines during pregnancy does not increase the risk of adverse pregnancy outcomes or birth defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Kuznetsova, A., Ceregido, MA., Jourquin, A., et al.[2022]

The Tdap5 vaccine administered during pregnancy between 27 and 36 weeks' gestation is highly effective, showing a 92.5% effectiveness in preventing pertussis in infants under 2 months old, based on a case-control study of 160 infant cases and 302 matched controls.

Vaccination of parents after pregnancy or less than 14 days before delivery does not provide protection against pertussis for infants, highlighting the importance of timing for vaccination during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. Vargas-Zambrano, JC., Clark, LR., Johnson, DR., et al.[2023]

In a study of 1,759 women, Tdap vaccination during pregnancy was linked to a lower likelihood of cesarean delivery, suggesting a potential benefit for maternal outcomes.

Importantly, the study found no adverse effects on infant outcomes associated with maternal Tdap vaccination, indicating that it is a safe option for protecting infants from pertussis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal and infant outcomes among women vaccinated against pertussis during pregnancy. Berenson, AB., Hirth, JM., Rahman, M., et al.[2018]

A study involving 16,350 infants born to mothers vaccinated with the Tdap vaccine during the third trimester found no significant increase in the risk of congenital anomalies, supporting the safety of maternal immunization with Boostrix.

While some congenital anomaly body systems showed statistically significant elevated relative risks, these findings may be influenced by improved detection methods over time, suggesting that the biological link between the vaccine and birth defects is unlikely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies. Florea, A., Sy, LS., Ackerson, BK., et al.[2023]

Tdap vaccination coverage among pregnant individuals in Ontario rose significantly from 0.4% in 2011/12 to 29.2% in 2019/20, particularly after the 2018 recommendation for universal vaccination during pregnancy.

In 2019/20, 71.0% of those vaccinated received the Tdap shot within the recommended gestational window (27-32 weeks), highlighting the importance of timing for optimal protection against pertussis for newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends and characteristics of Tdap vaccination during pregnancy in Ontario, Canada: a retrospective cohort study. Fakhraei, R., Fung, SG., Petrcich, W., et al.[2023]

The study analyzed data from 1182 women who received the Tdap5 vaccine during pregnancy and found that the rates of maternal and pregnancy complications were similar to or lower than those in the general pregnant population, indicating the vaccine's safety.

Among pregnancies with known outcomes, 90.4% resulted in live births, and only a small percentage experienced adverse outcomes, suggesting that Tdap5 vaccination during pregnancy does not pose significant risks to maternal or neonatal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry. Switzer, C., Tikhonov, I., Khromava, A., et al.[2022]

In a study of 403 infants whose mothers received the Tdap vaccine during pregnancy, no significant adverse outcomes were observed, including birth weight, gestational age, or congenital anomalies, indicating the vaccine's safety for both mothers and infants.

The study found that infants exposed to the Tdap vaccine were more likely to receive their vaccinations on time and none developed pertussis, supporting the vaccine's role in preventing pertussis infection in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant outcomes after exposure to Tdap vaccine in pregnancy: an observational study. Walls, T., Graham, P., Petousis-Harris, H., et al.[2018]

Out of 132 reports of pregnant women receiving the Tdap vaccine, 42% reported no adverse events, indicating a generally favorable safety profile for the vaccine during pregnancy.

The most common adverse event reported was spontaneous abortion in 16.7% of cases, but no maternal or infant deaths were recorded, suggesting that Tdap does not pose significant risks to mothers or their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. Zheteyeva, YA., Moro, PL., Tepper, NK., et al.[2022]

Vaccination with Adacel or Adacel-Polio during pregnancy provides high protection against pertussis disease in newborns, with effectiveness rates between 91-93%.

The vaccine is well tolerated by pregnant women and does not lead to complications during pregnancy or for the newborn, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review. Clark, LR., Johnson, DR.[2023]

In a study of 201 pregnant women vaccinated with the Tdap vaccine, 23.9% experienced at least one adverse event following immunization, with common symptoms including pain (22.4%) and swelling (2.5%).

All reported adverse events were expected and consistent with the vaccine's package insert, with no serious or unexpected events, indicating that the Tdap vaccine is safe for use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. Gattás, VL., Luna, EJA., Sato, APS., et al.[2021]

A study involving 29,155 pregnant women found that receiving the Tdap vaccine during pregnancy, even if administered less than 2 years after a prior tetanus-containing vaccine, did not lead to an increased risk of acute adverse events or negative birth outcomes.

The results indicate that recent vaccination does not pose additional risks, supporting the safety of Tdap vaccination in pregnant women regardless of their prior immunization history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations. Sukumaran, L., McCarthy, NL., Kharbanda, EO., et al.[2022]

In a study of 68,550 pregnant women in New Zealand, Tdap vaccination during pregnancy was found to be safe, with no increase in rates of serious adverse outcomes such as preterm labor or pre-eclampsia.

The Tdap vaccine may even have protective effects against certain conditions like pre-eclampsia with severe features and preterm delivery, providing further reassurance about its safety during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pertussis Immunisation in Pregnancy Safety (PIPS) Study: A retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccine. Griffin, JB., Yu, L., Watson, D., et al.[2019]

The Tdap vaccines, ADACEL and BOOSTRIX, are recommended for adults and adolescents to protect against pertussis, but there is insufficient evidence regarding their safety for pregnant women and their fetuses.

The CDC recommends that pregnant women who have not previously received Tdap should get vaccinated in the immediate postpartum period, while also considering the timing of Td vaccinations to ensure protection against tetanus and diphtheria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). Murphy, TV., Slade, BA., Broder, KR., et al.[2022]

In a study of 6,577 deliveries at Texas Children's Hospital, Tdap vaccine uptake during pregnancy increased significantly from 36% to over 61% after implementing awareness strategies, such as faculty presentations and the ACOG toolkit.

95% of women who received the Tdap vaccine during pregnancy did so at the recommended gestational age of 27-36 weeks, which is optimal for transferring maternal antibodies to the fetus, although Black women had lower uptake rates compared to other racial/ethnic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetanus and diphtheria toxoids and acellular pertussis vaccine uptake during pregnancy in a metropolitan tertiary care center. Healy, CM., Ng, N., Taylor, RS., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Maternal and infant outcomes among women vaccinated against pertussis during pregnancy. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Trends and characteristics of Tdap vaccination during pregnancy in Ontario, Canada: a retrospective cohort study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Infant outcomes after exposure to Tdap vaccine in pregnancy: an observational study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review. [2023]

10. Brazil pubmed.ncbi.nlm.nih.gov

Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Pertussis Immunisation in Pregnancy Safety (PIPS) Study: A retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccine. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Tetanus and diphtheria toxoids and acellular pertussis vaccine uptake during pregnancy in a metropolitan tertiary care center. [2018]