10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study. Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination. At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1). At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator. If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1. Brief description of the study design for TDA202 10-year follow-up study: This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202) conducted from July 2015 to November 2016. Only those who were enrolled in the initial TDA202 study and had completed TDA202 1-year follow-up will be recruited for this 10-year follow-up study. Participants from all 3 vaccine groups (i.e., participants who had received a single dose of one of the 3 study vaccines (Boostagen®, Pertagen®, or Adacel®) and completed 1-year follow-up visit at Day 336±28 days during the TDA202 study will be called in for informed consent process at Visit 0 (Screening) at approximately 10 years (range, 9.5-10 years) following vaccination. At Visit 0, Screening visit, participants who have signed the written Informed Consent Forms will be screened for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination) and those who fulfill the pre-defined inclusion criteria without meeting any exclusion criteria will be enrolled into the study. The screening visit and Visit 1 (Day 0) can be completed on the same day. Once enrolled, a blood sample (approx. 5 mL) will be taken from all participants at Visit 1 (before second booster vaccination) and at Visit 2 (28 days after second booster vaccination) as shown in the diagram below (Figure 1). At Visit 1, Day 0 (enrollment and second booster vaccination), a blood sample (approx. 5 mL) will be taken from all enrolled participants. After blood collection, the participants who received Pertagen® and Boostagen® in the initial TDA202 study will be administered a single intramuscular injection of a second booster dose of Pertagen®. The participants who have received Adacel® in the initial TDA202 study will be given a single intramuscular injection of a second booster dose of Adacel® (Table 1). Composition of booster vaccines are presented in Table 2. The vaccine preparation and administration will be performed by appropriately trained study team and study nurses, respectively, who are delegated by the Principal Investigator. If a participant does not complete screening visit and Visit 1 (Day 0) on the same day, the screening process for general health status (medical history, medication history, immunization history, history of receiving blood, blood component, immunoglobulin, immunosuppressive drugs or systemic corticosteroid, vital signs and physical examination), urine pregnancy test for female participants with childbearing potential and inclusion and exclusion criteria will be assessed again at Visit 1. Table 1: Vaccine groups and booster dose vaccination Vaccine group in Initial TDA202 study Second booster vaccination at Day 0 Total number of participants (N) per vaccine group Pertagen® and Boostagen® Pertagen® 84 Adacel® Adacel® 42 After the second booster vaccination, participants will be observed at the study site for at least 30 minutes to monitor for any immediate post-immunization reactions. Safety and reactogenicity in the participants will be assessed until end of study. The diary cards will be distributed to the participants to record post-immunization solicited local and systemic adverse events (AEs) until Day 7 and unsolicited AEs, serious adverse events (SAEs), and concomitant medications until Day 28 following vaccination. The study staff will contact the participants by phone on Day 7 (+4 days) to enquire on health status and to remind them to record any solicited local and systemic AEs, unsolicited AE, SAE and concomitant medications in the diary card. At Visit 2, Day 28 (+7 days), participants will return to the study site for blood sample collection (approx. 5 mL), reconciliation of information in the diary card, and any reported AEs, SAEs and concomitant medications. Safety and reactogenicity will be assessed until end of study. Solicited local and systemic AEs will be collected until Day 7 after the second booster vaccination. Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) will be collected until Visit 2 (Day 28) after the second booster vaccination. Visit 2 is considered the end of study. Blood samples collected from all participants at Day 0 (Visit 1) and Day 28 (Visit 2) will be processed for serum preparation. Serum samples will be stored at the laboratory at the study site and will be further shipped to BioNet-Asia Human Serology Laboratory where immunogenicity testing will be performed. At Day 0 (Visit 1) and Day 28 (Visit 2), ELISA testing to detect antibodies against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and PT neutralizing assay in Chinese Hamster Ovary (CHO) cells will be performed for all enrolled participants. At Day 0 (Visit 1), ELISA testing to detect antibodies against tetanus toxoid (TT) and diphtheria toxoid (DT) will be performed for participants who received Boostagen® and Adacel® in TDA202 initial study. Data management and statistical analysis will be performed by the Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand.