A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)

NCT05112848
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Phase
Phase 2
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Recruitment status
Completed
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Participants
384
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Lead sponsor
Novavax
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Start date
2022-02-28
clinicaltrials.gov
Number of sites
7
clinicaltrials.gov

Summary
This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.
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Acronym
COVID-19
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Short title
A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)
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Official title
A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in People Living With HIV
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2022-11-30
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First posted
2021-11-09
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Registry last updated
2023-03-16
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Primary completion date
2022-05-23
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Start date
2022-02-28
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Actual participants
384
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Participants
384
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
7
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Novavax
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05112848
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ClinicalTrials.gov ID
NCT05112848
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of PLWH with unsolicited adverse events (AEs)

    Timeframe: Day 84

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

  2. Number of HIV-Negative participants with unsolicited AEs

    Timeframe: Day 84

    Number of HIV-Negative participants with unsolicited AEs.

  3. Number of PLWH with unsolicited AEs

    Timeframe: Day 120

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

  4. Number of PLWH with unsolicited AEs

    Timeframe: Day 180

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

  5. Number of HIV-Negative participants with unsolicited AEs

    Timeframe: Day 120

    Number of HIV-Negative participants with unsolicited AEs.

  6. Number of HIV-Negative participants with unsolicited AEs

    Timeframe: Day 180

    Number of HIV-Negative participants with unsolicited AEs.

  7. Number of PLWH with solicited systemic AEs

    Timeframe: Day 0

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  8. Number of PLWH with solicited systemic AEs

    Timeframe: Day 21

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  9. Number of PLWH with solicited systemic AEs

    Timeframe: Day 70

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  10. Number of HIV-Negative participants with solicited systemic AEs

    Timeframe: Day 0

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

  11. Number of HIV-Negative participants with solicited systemic AEs

    Timeframe: Day 21

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

  12. Number of HIV-Negative participants with solicited systemic AEs

    Timeframe: Day 70

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

  13. Number of PLWH with solicited local AEs

    Timeframe: Day 0

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  14. Number of PLWH with solicited local AEs

    Timeframe: Day 21

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  15. Number of PLWH with solicited local AEs

    Timeframe: Day 70

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

  16. Number of HIV-Negative participants with solicited local AEs

    Timeframe: Day 0

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

  17. Number of HIV-Negative participants with solicited local AEs

    Timeframe: Day 21

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

  18. Number of HIV-Negative participants with solicited local AEs

    Timeframe: Day 70

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

  19. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Timeframe: Day 21

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

  20. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Timeframe: Day 35

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

  21. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Timeframe: Day 70

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

  22. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Timeframe: Day 84

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

  23. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Timeframe: Day 21

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

  24. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Timeframe: Day 35

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

  25. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Timeframe: Day 70

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

And 23 more, listed on the interactive page.

  1. Serum IgG antibody levels expressed as GMEU

    Timeframe: Day 21

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

  2. Serum IgG antibody levels expressed as GMEU

    Timeframe: Day 35

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

  3. Serum IgG antibody levels expressed as GMEU

    Timeframe: Day 70

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

  4. Serum IgG antibody levels expressed as GMEU

    Timeframe: Day 84

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

  5. Serum IgG antibody levels expressed as GMFR

    Timeframe: Day 21

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

  6. Serum IgG antibody levels expressed as GMFR

    Timeframe: Day 35

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

  7. Serum IgG antibody levels expressed as GMFR

    Timeframe: Day 70

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

  8. Serum IgG antibody levels expressed as GMFR

    Timeframe: Day 84

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

  9. Serum IgG antibody levels expressed as SCR

    Timeframe: Day 21

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

  10. Serum IgG antibody levels expressed as SCR

    Timeframe: Day 35

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

  11. Serum IgG antibody levels expressed as SCR

    Timeframe: Day 70

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

  12. Serum IgG antibody levels expressed as SCR

    Timeframe: Day 84

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  1. Adults 18 to 65 years of age, inclusive, at screening.

  2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.

  3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.

    1. Condoms (male or female) with spermicide (if acceptable in-country)
    2. Diaphragm with spermicide
    3. Cervical cap with spermicide
    4. Intrauterine device
    5. Oral or patch contraceptives
    6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy.
    7. Abstinence as a form of contraception is acceptable if in line with the participant's lifestyle.

  4. Vital signs must be within medically acceptable ranges prior to the first vaccination

  5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

    For well-controlled PLWH

  6. PLWH with a cluster of differentiation 4 (CD4) + T-cell count of ≥ 350 cells/μL at screening or viral load of ≤ 1,000 copies/mL.

  7. PLWH being managed on a stable/unchanged antiretroviral therapy (ART) regimen for at least 2 months prior to enrollment.

  8. No opportunistic infections in the past year.

    For less-well-controlled PLWH

  9. PLWH with a CD4+ T-cell count of ≥ 200 and < 350 cells/μL at screening or viral load of 1,000 to 10,000 copies/mL.

  10. PLWH being managed on a stable/unchanged (ART) regimen for at least 1 month prior to enrollment.

  1. Laboratory-confirmed SARS-CoV-2 infection (PCR+ within 5 days prior to first study vaccination with results available before randomization) or positive anti-S protein antibody to SARS-CoV-2 at screening.
  2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of COVID-19.
  3. Participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination.
  4. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
  5. Any known allergies to products contained in the investigational product.
  6. Any history of anaphylaxis to any prior vaccine.
  7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  8. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
  11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
  12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
  13. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
  14. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).
Sources for eligibility
clinicaltrials.gov

  • KwaPhila Health Solutions (Enhancing Care)Westridge, South Africa
  • Josha ResearchBloemfontein, South Africa
  • The Aurum Institute Pretoria Clinical Research ServicesPretoria, South Africa
  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research UnitDiepkloof, South Africa
  • Wits RHI Shandukani Research CentreHillbrow, South Africa
  • MERC Research (Pty) Ltd - MiddelburgMiddelburg, South Africa
  • Madibeng Centre for ResearchBrits, South Africa
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)