Clinical trial NCT05515042: Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.
Official title: A Phase 2a Trial to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected and HIV-uninfected Adults.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: COVID-19
Keywords: Vaccines
Lead sponsor: The Aurum Institute NPC
Sponsor class: OTHER
Collaborators: name: Coalition for Epidemic Preparedness Innovations
First posted: 2022-08-25
Enrollment: 694
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination with a single dose Janssen (Group 1), 2 doses of Pfizer (Group 2) or no prior COVID-19 vaccination with evidence of prior SARS-CoV-2 infection (Group 3). A total of 300 participants per group will be enrolled in Groups 1 and 2 (255 HIV-infected and 45 HIV-uninfected per group), and 150 HIV-infected, unvaccinated participants in Group 3. Each treatment regimen (Vaccine Arm: A, B or C) will evaluate 250 participants. Groups 1 and 2 will enrol 85 HIV-infected and 15 HIV-uninfected per vaccine arm.
Primary purpose: PREVENTION

Brief summary: This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination with a single dose Janssen (Group 1), 2 doses of Pfizer (Group 2) or no prior COVID-19 vaccination with evidence of prior SARS-CoV-2 infection (Group 3) .A total of 300 participants per group will be enrolled in Groups 1 and 2 (255 HIV-infected and 45 HIV-uninfected per group), and 150 HIV-infected, unvaccinated participants in Group 3. Each treatment regimen (Vaccine Arm: A, B or C) will evaluate 250 participants. Groups 1 and 2 will enrol 85 HIV-infected and 15 HIV-uninfected per vaccine arm.


Eligibility criteria: Inclusion Criteria:

1. . Adult male or female aged 18 and above at the time of written informed consent
2. . Willing and able to give written informed consent
3. . HIV-infected persons on ART for at least three months prior to enrollment, or HIV-uninfected persons
4. . Able to provide evidence of completing a primary COVID-19 vaccination regimen with either a single dose of Ad26.COV2.S or two doses of BNT162b2 at least two months prior to enrolment, or HIV-infected with no prior COVID-19 vaccination and evidence of prior SAR-CoV-2 infection
5. . Residing in the vicinity of the clinical trial site and planning to remain in the area of the study for 12months
6. . Able and willing to participate for the duration of the study visits and follow-up
7. . Willing to provide verifiable identification (eg. Identity document, passport) at study entry and follow-up visits

Exclusion Criteria:

1. . Positive SARS-CoV-2 PCRor antigen detection test
2. . Persons with undocumented HIV status
3. . HIV-infected persons with CD4count \<1 00 cells/mm3and/or Viral Load \> 1000 copies/ml
4. . Known allergy or history of anaphylaxis or other serious adverse reactions to specific COVID-19 vaccine constituents
5. . History of capillary leak syndrome, thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia (HIT), history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood
6. . Participants with acute illness (this does not include minor illnesses such as diarrhoea or mild upper respiratory tract infection) or body temperature ≥38.0ºC on Day 1 will be excluded from randomization at that time but may be rescheduled for randomization and/or vaccination at a later date.
7. . Participants who cannot communicate reliably with the investigator
8. . Pregnant or breastfeeding
9. . Women of childbearing potential who are not on an effective long-acting contraceptive method for at least 21 days prior to enrollment (date of signed informed consent) and not intending to continue contraception for up to 9 months post first vaccination.(See Section 10.5.1 below)
10. . Prior administration of an investigational coronavirus vaccine (for example, SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome \[MERS-CoV\] vaccine), except for participants of the Sisonke trial
11. . Prior administration of any SARS-CoV-2 vaccine boost
12. . Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment
13. . History of harmful substance or alcohol use within the past 2 years. This exclusion does not apply to cannabis use.
14. . Receipt of:

    1. . Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of randomization (for corticosteroids, ≥20 mg/day prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the day of randomization. Inhaled, nasal, and topical steroids are allowed.
    2. . Intravenous blood products (red cells, platelets, immunoglobulins, monoclonal antibodies specific for SARS-CoV-2) within 3 months prior to enrollment
    3. . Experimental vaccine within the past 6 months before first vaccination
    4. . Any inactivated vaccines received within 14 days prior to first vaccination or planned within 14 days of first vaccination, or live attenuated vaccines received with 30 days prior to the first vaccination or planned within 30 days of the first vaccination.
15. . Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 1) or plans to do so while participating in this study.
16. . Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.

Primary outcomes:
measure: Primary Objective and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Primary Objective and Endpoint/Outcome 2:
timeFrame: 14 Months
Secondary outcomes:
measure: Secondary Objective 1 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Secondary Objective 1 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Secondary Objective 2 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Secondary Objective 2 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Secondary Objective 2 and Endpoint/Outcome 3:
timeFrame: 14 Months
measure: Secondary Objective 3 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Secondary Objective 3 and Endpoint/Outcome 2:
timeFrame: 14 Months
Other outcomes:
measure: Exploratory Objective 1 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Exploratory Objective 1 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Exploratory Objective 1 and Endpoint/Outcome 3:
timeFrame: 14 Months
measure: Exploratory Objective 2 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Exploratory Objective 2 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Exploratory Objective 3 and Endpoint/Outcome:
timeFrame: 14 Months
measure: Exploratory Objective 4 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Exploratory Objective 4 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Exploratory Objective 4 and Endpoint/Outcome 3:
timeFrame: 14 Months
measure: Exploratory Objective 5 and Endpoint/Outcome 1:
timeFrame: 14 Months
measure: Exploratory Objective 5 and Endpoint/Outcome 2:
timeFrame: 14 Months
measure: Exploratory Objective 5 and Endpoint/Outcome 3:
timeFrame: 14 Months
Locations:
city: Pretoria
country: South Africa
facility: The Aurum Institute: Pretoria Clinical Research Centre
state: Gauteng
city: Tembisa
country: South Africa
facility: The Aurum Institute: Tembisa Clinical Research Centre, Clinic 4
state: Gauteng
city: Tembisa
country: South Africa
facility: The Aurum Institute: Tembisa Clinical Research Centre
state: Gauteng
city: Klerksdorp
country: South Africa
facility: The Aurum Institute: Gavin J Churchyard Legacy Centre
state: North West Province
city: Rustenburg
country: South Africa
facility: The Aurum Institute: Rustenburg Clinical Research Centre
state: North-West Province
Study officials:
affiliation: The Aurum Institute NPC
name: Prof Gavin Churchyard, PhD
role: PRINCIPAL_INVESTIGATOR
References: