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This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-Mâ„¢ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.
The investigational product will be a monovalent Serum Institute of India (SII) SARS CoV-2 vaccine at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as NVX-CoV2373).
Approximately 270 PLWH, 18 to 65 years of age inclusive, will be enrolled into 3 groups and stratified at presentation based on the level of control of HIV infection. All PLWH will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. PLWH will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two dose regimen on Days 0 and 21 or Days 0 and 70 or a three-dose regimen on Days 0, 21, and 70. Randomization of PLWH will be stratified by level of control of HIV infection to distribute well controlled and less well controlled participants approximately evenly among the 3 PLWH treatment groups. Approximately 90 HIV negative participants, 18 to 65 years of age inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two dose regimen on Days 0 and 21 or Days 0 and 70. All HIV negative participants will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. Placebo (normal saline solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373 to maintain overall blinding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 PLWH | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
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| Group 2 PLWH | Experimental | Three doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70. |
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| Group 3 PLWH | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
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| Group 4 HIV-Negative Participants | Experimental | 2 doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
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| Group 5 HIV-Negative Participants | Experimental | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVX-CoV2373 | Biological | Alternating intramuscular (IM) (deltoid) injections of monovalent prototype vaccine premixed with Matrix-Mâ„¢ adjuvant (0.5 mL) given either as 2 doses (one on Day 0 and one on Day 21 or Day 70) and an injection of placebo (0.5mL) on Day 21 or Day 70, or 3 doses (Day 0, Day 21, and Day 70). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PLWH with unsolicited adverse events (AEs) | Number of PLWH with unsolicited AEs stratified by level of control of HIV infection. | Day 84 |
| Number of HIV-Negative participants with unsolicited AEs | Number of HIV-Negative participants with unsolicited AEs. | Day 84 |
| Number of PLWH with unsolicited AEs | Number of PLWH with unsolicited AEs stratified by level of control of HIV infection. | Day 120 |
| Number of PLWH with unsolicited AEs | Number of PLWH with unsolicited AEs stratified by level of control of HIV infection. | Day 180 |
| Number of HIV-Negative participants with unsolicited AEs | Number of HIV-Negative participants with unsolicited AEs. | Day 120 |
| Number of HIV-Negative participants with unsolicited AEs | Number of HIV-Negative participants with unsolicited AEs. | Day 180 |
| Number of PLWH with solicited systemic AEs | 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IgG antibody levels expressed as GMEU | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants. | Day 21 |
| Serum IgG antibody levels expressed as GMEU |
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Inclusion Criteria:
Adults 18 to 65 years of age, inclusive, at screening.
Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
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.
Vital signs must be within medically acceptable ranges prior to the first vaccination
Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
For well-controlled PLWH
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.
PLWH being managed on a stable/unchanged antiretroviral therapy (ART) regimen for at least 2 months prior to enrollment.
No opportunistic infections in the past year.
For less-well-controlled PLWH
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.
PLWH being managed on a stable/unchanged (ART) regimen for at least 1 month prior to enrollment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development | Novavax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KwaPhila Health Solutions (Enhancing Care) | Westridge | Durban | 4091 | South Africa | ||
| Josha Research |
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| Number of PLWH with solicited systemic AEs |
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. |
| Day 21 |
| Number of PLWH with solicited systemic AEs | 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. | Day 70 |
| Number of HIV-Negative participants with solicited systemic AEs | Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination. | Day 0 |
| Number of HIV-Negative participants with solicited systemic AEs | Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination. | Day 21 |
| Number of HIV-Negative participants with solicited systemic AEs | Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination. | Day 70 |
| Number of PLWH with solicited local AEs | 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. | Day 0 |
| Number of PLWH with solicited local AEs | 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. | Day 21 |
| Number of PLWH with solicited local AEs | 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. | Day 70 |
| Number of HIV-Negative participants with solicited local AEs | Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination. | Day 0 |
| Number of HIV-Negative participants with solicited local AEs | Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination. | Day 21 |
| Number of HIV-Negative participants with solicited local AEs | Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination. | Day 70 |
| Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU) | 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. | Day 21 |
| Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU) | 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. | Day 35 |
| Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU) | 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. | Day 70 |
| Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU) | 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. | Day 84 |
| Serum IgG antibody levels expressed as geometric mean fold rise (GMFR) | 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. | Day 21 |
| Serum IgG antibody levels expressed as geometric mean fold rise (GMFR) | 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. | Day 35 |
| Serum IgG antibody levels expressed as geometric mean fold rise (GMFR) | 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. | Day 70 |
| Serum IgG antibody levels expressed as geometric mean fold rise (GMFR) | 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. | Day 84 |
| Serum IgG antibody levels expressed as seroconversion rate (SCR) | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection. | Day 21 |
| Serum IgG antibody levels expressed as seroconversion rate (SCR) | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection. | Day 35 |
| Serum IgG antibody levels expressed as seroconversion rate (SCR) | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection. | Day 70 |
| Serum IgG antibody levels expressed as seroconversion rate (SCR) | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection. | Day 84 |
| Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT) | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 21 |
| Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT) | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 35 |
| Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT) | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 70 |
| Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT) | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 84 |
| hACE2 receptor binding inhibition assay expressed as GMFR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 21 |
| hACE2 receptor binding inhibition assay expressed as GMFR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 35 |
| hACE2 receptor binding inhibition assay expressed as GMFR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 70 |
| hACE2 receptor binding inhibition assay expressed as GMFR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 84 |
| hACE2 receptor binding inhibition assay expressed as SCR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 21 |
| hACE2 receptor binding inhibition assay expressed as SCR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 35 |
| hACE2 receptor binding inhibition assay expressed as SCR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 70 |
| hACE2 receptor binding inhibition assay expressed as SCR | Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 84 |
| Neutralizing antibody activity expressed as GMT | Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 35 |
| Neutralizing antibody activity expressed as GMT | Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection. | Day 84 |
| Neutralizing antibody activity expressed as SCR | Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 35 |
| Neutralizing antibody activity expressed as SCR | Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection. | Day 84 |
| Neutralizing antibody activity expressed as GMFR | Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 35 |
| Neutralizing antibody activity expressed as GMFR | Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection. | Day 84 |
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.
| Day 35 |
| Serum IgG antibody levels expressed as GMEU | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants. | Day 70 |
| Serum IgG antibody levels expressed as GMEU | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants. | Day 84 |
| Serum IgG antibody levels expressed as GMFR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants. | Day 21 |
| Serum IgG antibody levels expressed as GMFR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants. | Day 35 |
| Serum IgG antibody levels expressed as GMFR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants. | Day 70 |
| Serum IgG antibody levels expressed as GMFR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants. | Day 84 |
| Serum IgG antibody levels expressed as SCR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants. | Day 21 |
| Serum IgG antibody levels expressed as SCR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants. | Day 35 |
| Serum IgG antibody levels expressed as SCR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants. | Day 70 |
| Serum IgG antibody levels expressed as SCR | Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants. | Day 84 |
| Bloemfontein |
| Free State |
| 9301 |
| South Africa |
| The Aurum Institute Pretoria Clinical Research Services | Pretoria | Gauteng | 0087 | South Africa |
| Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit | Diepkloof | Johannesburg | 1862 | South Africa |
| Wits RHI Shandukani Research Centre | Hillbrow | Johannesburg | 2001 | South Africa |
| MERC Research (Pty) Ltd - Middelburg | Middelburg | Mpumalanga | 1055 | South Africa |
| Madibeng Centre for Research | Brits | North West | 250 | South Africa |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000711928 | NVX-CoV2373 adjuvated lipid nanoparticle |
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