Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine

NCT05109559 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: VAC31518COV2012
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are documented to have received either 1-dose or 2-doses (primary series completion) of inactivated COVID-19 vaccines, Sinovac and/or Sinopharm.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2; COVID-19; booster; Heterologous

Outcome Measures

Primary Outcomes (18)

• Frequency of solicited reportable local adverse event after vaccination

  Frequency and percentage of solicited reportable local adverse events (pain or tenderness, erythema, swelling or induration) of vaccination

  Day 0 through Day 7

• Frequency of solicited reportable systemic adverse event after vaccination

  Frequency and percentage of solicited reportable systemic adverse events (fever, headache, fatigue or malaise, myalgia, arthralgia, nausea or vomitting) of vaccination

  Day 0 through Day 7

• Frequency of all unsolicited AEs

  Frequency and percentage of all unsolicited AEs

  : Day 0 through Day 336

• GMT Anti-S IgG at baseline

  GMT Anti-S IgG at baseline

  Day 0

• GMT Anti-S IgG at 7 days after vaccination in subset subjects

  GMT Anti-S IgG at 7 days after vaccination in subset subjects

  Day 7

• GMT Anti-S IgG at 14 days after vaccination in subject subjects

  GMT Anti-S IgG at 14 days after vaccination in subset subjects

  Day 14

• GMT Anti-S IgG at 28 days after vaccination

  GMT Anti-S IgG at 28 days after vaccination

  Day 28

• GMT Anti-S IgG at 84 days after vaccination

  GMT Anti-S IgG at 84 days after vaccination

  Day 84

• GMT Anti-S IgG at 168 days after vaccination

  GMT Anti-S IgG at 168 days after vaccination

  Day 168

• GMT Anti-S IgG at 336 days after vaccination

  GMT Anti-S IgG at 336 days after vaccination

  Day 336

• GMFR changed from baseline in anti-S IgG GMT at 28 days after vaccination

  GMFR changed from baseline in anti-S IgG GMT at 28 days vaccination

  Day 28

• GMFR changed from baseline in anti-S IgG GMT at 84 days after vaccination

  GMFR changed from baseline in anti-S IgG GMT at 84 days vaccination

  Day 84

• GMFR changed from baseline in anti-S IgG GMT at 168 days after vaccination

  GMFR changed from baseline in anti-S IgG GMT at 168 days vaccination

  Day 168

• GMFR changed from baseline in anti-S IgG GMT at 336 days after vaccination

  GMFR changed from baseline in anti-S IgG GMT at 336 days vaccination

  Day 336

• Anti-S IgG Seroresponses changed from baseline at 28 days after vaccination

  Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 28 days after vaccination

  Day 28

• Anti-S IgG Seroresponses changed from baseline at 84 days after vaccination

  Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 84 days after vaccination

  Day 84

• Anti-S IgG Seroresponses changed from baseline at 168 days after vaccination

  Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 168 days after vaccination

  Day 168

• Anti-S IgG Seroresponses changed from baseline at 336 days after vaccination

  Frequency and percentage of participants with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline at 336 days after vaccination

  Day 336

Secondary Outcomes (9)

• GMT measured by pseudovirus neutralization assay (pNA) and microneutralization assay (mNA) Neutralizing antibody titer 50 at baseline

  Day 0

• GMT measured by pseudovirus neutralization assay (pNA) and microneutralization assay (mNA) Neutralizing antibody titer 50 at 28 days after Ad26.COV2.S vaccination

  Day 28

• GMT measured by pseudovirus neutralization assay (pNA) and microneutralization assay (mNA) Neutralizing antibody titer 50 at 84 days after Ad26.COV2.S vaccination

  Day 84

• GMT measured by pseudovirus neutralization assay (pNA) and microneutralization assay (mNA) Neutralizing antibody titer 50 at 168 days after Ad26.COV2.S vaccination

  Day 168

• GMT measured by pseudovirus neutralization assay (pNA) and microneutralization assay (mNA) Neutralizing antibody titer 50 at 336 days after Ad26.COV2.S vaccination

  Day 336

Study Arms (4)

Ad26.COV2.S given at the interval ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm

EXPERIMENTAL

Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria. In study part A1, a total of 360 adult volunteers aged 18 years or older, will receive the full-dose (5x10\^10 vp) of the study product, at later (90 days or more) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.

Biological: Full dose of Ad26.COV2. 5x10^10vp

Ad26.COV2.S given at 45-75 days after completing 2 doses of either Sinovac or Sinopharm

EXPERIMENTAL

Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria. In study part A2, a total of 110 adult volunteers aged 18 years or older, will receive the full-dose (5x10\^10 vp) of the study product, at early (45-75 days) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.

Biological: Full dose of Ad26.COV2. 5x10^10vp

Half dose of Ad26.COV2.S given ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm

EXPERIMENTAL

Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria. In study part A3, a total of 110 adult volunteers aged 18 years or older, will receive the half-dose (2.5x10\^10 vp) of the study product, at later (90 days or more) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.

Biological: Half dose of Ad26.COV2. 2.5x10^10vp

Ad26.COV2.S given 28 days after receiving 1 dose of either Sinovac or Sinopharm

EXPERIMENTAL

Study Part B is a prospective, multi-center, open-label Phase 1/2 heterologous prime-boost study to assess the Ad26.COV2.S (full dose 5x10\^10 vp) as the 2nd vaccination in subjects who are documented to all have received the 1st dose of Sinovac or all received the 1st dose of Sinopharm COVID-19 vaccine, with an interval of 28 days +/- 3 days, followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.

Biological: Full dose of Ad26.COV2. 5x10^10vp

Interventions

Full dose of Ad26.COV2. 5x10^10vp BIOLOGICAL

A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.

Ad26.COV2.S given at 45-75 days after completing 2 doses of either Sinovac or Sinopharm; Ad26.COV2.S given at the interval ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm

Half dose of Ad26.COV2. 2.5x10^10vp BIOLOGICAL

A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.

Half dose of Ad26.COV2.S given ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female aged 18 years or more on the day of signing the ICF, confirmed by identification cards.
• Verified, documentation of past COVID-19 vaccination i. Study Part A: having completed the 2-dose homologous primary regimen (21 to 35 days apart) of inactivated COVID-19 vaccine of either Sinovac-Sinovac OR Sinopharm-Sinopharm ii. Study Part B: having received one dose of inactivated COVID-19 vaccine of either Sinovac or Sinopharm with the appropriate interval period
• Women of childbearing potential who are test negative with a highly sensitive urine pregnancy test at Visit 1, prior to study vaccine administration.
• Subject has provided written informed consent prior to performance of any study-specific procedures and is willing and has means to be contacted and to contact the investigator during the study.
• In the investigator's clinical judgment, the participant is in good health, or has stable and well-controlled medical conditions.
• Participant agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine.

You may not qualify if:

• The participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a patient under investigation (PUI) or has a body temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned study vaccination. Assignment may be made at a later date is permitted at the discretion of the investigator. Please notify the Sponsor (or medical monitor) of this decision.
• Contraindication to Ad26.COV2.S according to labelling of the product. For example, if the participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine;refer to the IB (IB Edition 5 Ad26.COV2.S 2021 and its addenda).
• Pregnant or planning to become pregnant within 3 months after study vaccine administration
• Participant has a history or current condition as follows
• Known documented history of COVID-19 infection prior to enrollment
• Any confirmed or suspected immunosuppressive or immunodeficient state.
• Heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia.
• Acute polyneuropathy (e.g. Guillain-Barré syndrome).
• Capillary leak syndrome
• Contraindication to IM injections and blood draws e.g., bleeding disorders.
• An underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well being) or that could prevent, limit, or confound the protocol-specified assessments.
• Major psychiatric illness which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures.
• If the participant received or plans to receive:
• Licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine.
• Other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine.

Sponsors & Collaborators

• Mahidol University: lead
• National Vaccine Institute, Thailand: collaborator
• International Vaccine Institute: collaborator
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,

Bangkok, 10400, Thailand

RECRUITING

Related Publications (2)

• Muangnoicharoen S, Wiangcharoen R, Lawpoolsri S, Nanthapisal S, Jongkaewwattana A, Duangdee C, Kamolratanakul S, Luvira V, Thanthamnu N, Chantratita N, Thitithanyanont A, Anh Wartel T, Excler JL, Ryser MF, Leong C, Mak TK, Pitisuttithum P. Heterologous Ad26.COV2.S booster after primary BBIBP-CorV vaccination against SARS-CoV-2 infection: 1-year follow-up of a phase 1/2 open-label trial. Vaccine. 2024 Jul 25;42(19):3999-4010. doi: 10.1016/j.vaccine.2024.05.010. Epub 2024 May 13.

  PMID: 38744598 DERIVED

• Muangnoicharoen S, Wiangcharoen R, Nanthapisal S, Kamolratakul S, Lawpoolsri S, Jongkaewwattana A, Thitithanyanont A, Luvira V, Chinwangso P, Thanthamnu N, Chantratita N, Lim JK, Anh Wartel T, Excler JL, Ryser MF, Leong C, Mak TK, Pitisuttithum P. Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial. Vaccine. 2023 Jul 19;41(32):4648-4657. doi: 10.1016/j.vaccine.2023.06.043. Epub 2023 Jun 15.

  PMID: 37344265 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Punnee Pitisuttithum, MD

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  STUDY CHAIR

Central Study Contacts

Sant Muangnoicharoen, MD

CONTACT

+66851998989; sant.mua@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 5, 2021
• Study Start: December 20, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)