Extension study of DV2-TDAP-01 to assess immunogenicity of Tdap-1018 to pertussis antigens.

Extension Study to DV2-TDAP-01 to Assess Immunogenicity to Pertussis Antigens Two and a Half to Three Years Following Study Injection or Boostrix

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12624000233527

Enrollment

Registered

2024-03-11

Start date

2024-02-08

Completion date

2024-07-30

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a non interventional extension study to assess immunogenicity of Tdap-1018 3000 mcg and Boostrix approximately 2.5 to 3 years after study injection in Study DV2-TDAP-01. Adult individuals who participated in Dynavax-sponsored study DV2-TDAP-01 and received either Tdap-1018 3000 mcg or Boostrix will be invited to return 2.5 to 3 years (± 60 days) after the DV2-TDAP-01 study injection for a follow-up blood draw. This is an extension study to ACTRN12620001177943.

Interventions

This is a non- interventional clinical study. This is an extension study to assess immunogenicity of Tdap-1018 3000 mcg (Tdap with 3000 mcg of 1018) and Boostrix approximately 2.5 to 3 years after study injection in Study DV2-TDAP-01. Participants will be invited to return approximately 2.5 to 3 years after the DV2-TDAP-01 study injection for a follow up blood draw. Participants received Tdap-1018 3000 mcg or Boostrix in ACTRN12620001177943 and participants must have been a part of ACTRN12620001177943 in order to be included in this study. Participants will also be asked for consent to collect data from medical records and for a blood sample. Up to 57 adult participants will be enrolled and the total duration of individual participation in this study is only one day.

Eligibility

Sex/Gender

All

Age

18 Years to 26 Years

Healthy volunteers

Yes

Inclusion criteria

A participant must meet the following criteria to be eligible for enrollment and participation in the study: 1) Willing to participate; informed consent provided for the study 2) Male or female, 18 to 22 years of age at time of receipt of Tdap-1018 3000 mcg or Boostrix injection in Dynavax study DV2-TDAP-01 3) Able to comprehend and follow all required study procedures 4) All participants must have been a part of ACTRN12620001177943 in order to be included in this study.

Exclusion criteria

A participant with any 1 of the following criteria is not eligible for enrollment in the study: 1) Vaccinated against pertussis following receipt of the DV2-TDAP-01 injection and prior to date of study visit in DV2-TDAP-101 2) Any other finding that the Investigator considers will make the subject unsuitable for the study

Outcome results