ChAdOx1 Two doses UK Frater et al. [139]
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Phase 2/3 |
54 PLWH (all male), Median age 42.5 years (IQR 37.5–49.8) 50 HIV negative (24 female, 25 male), Median age 38.5 years (IQR 29.2–45.0)
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Not part of study criteria |
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Replication deficient adenoviral vector vaccine induces response in PLWH Comparable cellular and humoral responses (magnitude or persistence of response) to HIV-negative participants No correlation between the magnitude of the anti-spike IgG response at Day 56 and CD4+ T cell count (P = 0.93) or age (P = 0.48)
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ChAdOx1 Two doses South Africa Madhi et al. [140]
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Randomized, double-blind, placebo-controlled, phase 1B/2A trial |
103 PLWH 51 Placebo (11 male, 40 female), Median age 41 years (IQR 33–46) 52 Vaccinated (16 male, 36 female), Median age 37 years (IQR 36–46) 58 HIV negative 31 Placebo (19 male, 10 female), Median age 31 years (IQR 26–42) 29 vaccinated (17 male, 12 female), Median age 34 years (range 23–41)
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All PLWH on ART for at least 3 months Plasma viral load >100 copies/ml Median CD4+ T cell count 695, (IQR 512–929)
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Binding antibody (ELISA) Neutralization
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Replication deficient adenoviral vector vaccine induces response in PWLH Participants testing seropositive at baseline had higher levels of spike antibodies and neutralizing titres regardless of HIV status Antibody and neutralization titres increased in all participants following second dose of vaccine
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Ad26.CoV2. S Single dose South Africa Khan et al. [141]
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Participants from the SISONKE South African clinical |
26 PLWH (i) Infected unvaccinated n = 34 (7 male and 27 female), Median age 41 years (ii) infected vaccinated n = 18 All female, Median age 47 years (iii) vaccinated only n = 8, (1 male and 7 female) 73 HIV negative between 3 groups
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All PLWH receiving ART 10 viraemic SARS-CoV-2 infected and unvaccinated (HIV viral load 1224–30 160 copies/ml), Median CD4+ T cell count 581 1 viraemic SARS-CoV-2 vaccinated (HIV viral load 3219 copies/ml), Median CD4+ T cell count 852 Non-viraemic vaccinated, participants, Median CD4+ T-cell count 735
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Actively enrolled unvaccinated and vaccinated participants with prior SARS-COV-2 infection |
Neutralization vs. Delta variant only |
Participants with well controlled HIV had comparable neutralization of delta variant, regardless of prior SARS-CoV-2 infection Weakest responses seen in unvaccinated PLWH with prior SAR-CoV-2 infection, particularly in those with HIV viraemia
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Pilot study |
12 PLWH (5 male and 7 female), Median age 52 years (IQR 25–59) 17 HIV negative (7 female and 10 male), Median age 41 years (IQR 24–59)
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No evidence of prior SARS-CoV-2 infection (determined by lack of detectable nucleocapsid antibodies) |
CD4 and CD8 ELISpot Anti-spike IgG—ELISA
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mRNA vaccine induces antibody responses in PLWH Magnitude and breadth of antibody and T cell responses not significantly different from HIV negative participants, which could be CD4+ T cell count dependent
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BNT162b2 (mRNA) Two doses Israel Levy et al. [144]
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Prospective open study |
143 PLWH (131 male and 12 female), Mean age 49.8 years 261 HIV negative (66 male and 195 female), Mean age 55.8 years
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Not part of study criteria |
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mRNA vaccine induces antibody responses in PLWH Total IgG responses to RBD lower in immunocompromised controls but neutralizing antibodies at similar level to controls Decrease in CD4+ T cell counts observed after each vaccine dose—may impact PLWH with low/unstable CD4+ T cell counts
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BNT162b2 (mRNA) Two doses Sweden Bergman et al. [145]
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Open-label, non-randomized prospective clinical trial |
90 PLWH (54 male and 36 female), 79% under 65 years 90 controls (29 male and 36 female), 70% under 65 Additional participants with primary immunodeficiency disorders or secondary immunodeficiency disorders (n = 90 per group)
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Latest CD4+ T cell count ≤ 300, n = 30 Latest CD4+ T cell count >300, n = 60
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Individuals with prior SARS-CoV-2 infection were excluded |
Anti-spike IgG (ELISA) |
The primary endpoint was seroconversion rate 2 weeks post second dose 100% of PLWH with CD4+ T cell counts >300 seroconverted following vaccination 96% of PLWH with CD4+ T cell counts <300 PLWH were the only secondary immunodeficiency group that did not have a higher likelihood to seroconvert
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Cohort observational study |
PLWH After prime n = 88 (75 male and 13 female), Mean age 53.8 years (range 26–86 years) After boost n = 52, (39 male and 13 female), Mean age 60.2 years (range 32–85) HCW (controls)
N = 41 after prime and boost (13 male and 28 female), Mean age 44 years (range 23–61)
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Viral load <50 copies/ml, n = 84 participants after prime and n = 51 participants after boost Viral load of 51–200 copies/ml, n = 4 participants after prime and n = 1 participant after boost Mean CD4+ T cell count 716 after prime and 577 after boost Mean nadir CD4+ T- cell count 257 after prime and 199 after boost
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Not included in study design |
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All PLWH receiving ART mounted a humoral response regardless of nadir CD4+ T cell count, current CD4+ T cell count, CD4:CD8 ratio after full vaccination. Overall levels of anti-RBD antibodies were variable HIV-negative controls produced significantly higher mean anti-RBD antibody concentrations with less variability
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Cohort observational study 3–4 weeks post-vaccination |
106 PLWH (90% male), Mean age 43 years (range 21–65) 20 HIV-negative HCW (healthcare workers), Mean age 47 years (range 21–59)
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CD4+ T cell count <250, n = 6 CD4+ T cell count 251–500, n = 18 CD4+ T cell count >500, n = 82 4 participants had detectable HIV viral load
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11 participants had seroconverted before vaccination and were excluded from study |
Anti-RBD IgG (ELISA) |
PLWH with CD4+ T cell counts >250 had comparable antibody responses to control group Lower CD4+ T cell counts resulted in weak responses Study suggests significant association of age single dose vaccine response
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mRNA-1273 Two doses Italy Lombardi et al. [148]
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Prospective single centre cohort |
71 PLHW (60 male and 11 female), Mean age 47 years 10 HIV-negative healthy controls (7 male and 3 female), Mean age 58 years
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9 PLWH and 2 healthy controls had prior infection with SARS-CoV-2 (Confirmed by antibodies to nucleocapsid) |
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Vaccination resulted in seroconversion and neutralizing antibody responses in PLWH on ART who were virally suppressed with good CD4+ T cell counts. Neutralizing antibody and anti-S antibody titres were like those displayed by healthy controls, even when stratified according to the CD4+ T cell count PLWH with prior SARS-CoV-2 infection displayed higher anti-S antibody titres (P = 0.0007) and neutralizing antibody activity in sera (P = 0.0007) than COVID-19-naïve PLWH
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Prospective observational cohort |
14 PLWH only (13 male and 1 female), Median age 62 years (IQR 56–70) |
All participants on ART for at least 6 months 13 participants had undetectable viral loads. 1 had detectable viral load (not stated) CD4+ T cell counts: <200, n = 2, CD4+ T cell count 200–349, n = 1, CD4+ T cell count 350–499, n = 3 CD4+ T cell count >500, n = 8
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Not included in study |
Binding IgG antibodies (RBD) (ELISA) |
2 doses of mRNA vaccine resulted in high binding antibody titres in PLWH with well-controlled HIV on ART, regardless of CD4+ T cell counts |
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Non-interventional, retrospective study |
665 PLWH mRNA vaccinated n = 590 (492 male, 8 female), Median age 52 years (IQR 43–59) Heterologous schedule n = 29 (25 male, 4 female), Median age—56 years (IQR 48–59) AstraZeneca vaccinated n = 31 (all male), Median age 31 years (IQR 49.5–63) Janssen vaccinated n = 15 (12 male), Median age 46 years (IQR 39.5–59)
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Whole study: HIV viral load: 93.5% of participants <50 copies/ml Median CD4+ T cell count 708 Median nadir CD4+ T cell 264
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Participants with Prior SARS-COV-2 infection were excluded from the study |
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Antibody levels achieved by PLWH following vaccination were comparable to general population mRNA containing vaccination schemes (homo or heterogeneous) had the highest antibody responses Vector-only vaccination scheme had lower median antibody responses Trend towards better responses in female participants Current CD4+ T cell count significantly associated with antibody responses
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Heterologous regimens Canada Brumme et al. [150]
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Non-interventional trial |
100 PLWH (88 male, 12 female), Median age 54 years (IQR 40–61) 152 HIV-negative controls (76 male, 76 female), Median age 47 years (IQR 35–70)
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Median CD4+ T cell count 710 |
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SARS-CoV-2 vaccination induces binding and neutralizing antibody responses in PLWH on ART with CD4 counts in healthy range Older participants and those with other underlying conditions had weaker responses Vaccination with 1 or 2 doses of mRNA vaccination as part of a 2-dose scheme produces higher peak antibody responses than viral vectored vaccination but waned quicker than 2 doses of ChAdOx1 Increased interval between vaccine doses resulted in high levels of binding antibodies but not neutralizing antibodies
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Prospective |
46 PLWH (40 male and 6 female), Mean age 38 years 40 HIV-negative controls, Mean age 34 years
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Median CD4 count 523 CD4+ T cell count <200, n = 2 CD4+ T cell count 200–349, n = 8 CD4+ T cell count 350–499, n = 11 CD4+ T cell count >500, n = 25
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Not included in study protocol |
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Interventional Study |
24 PLWH (12 male and 12 female), Median age 44 years, 24 HIV negative controls (15 male and 9 female), Median age 37 years.
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CD4+ and CD8+ T-cell count levels were enumerated by flow cytometry after vaccination but numbers prior to vaccination not available |
Excluded participants with prior history of exposure or infection with SAR-CoV-2 |
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Inactivated whole virus vaccine is safe and capable of inducing neutralizing antibody responses in PLWH The magnitude of neutralizing antibodies was lower compared to HIV-negative participants Lower CD4+ T cell and B cell levels observed following vaccination may explain these difference
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Open-label two-arm non-randomized study |
42 HIV (29 male and 13 female), Mean age 42.54 years 28 Healthy controls (16 males, 12 females), Mean age 37.79 years
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All HIV-positive participants required to have a CD4+ T cell count of >200 at baseline (mean CD4+ T cell count 659) and 4 weeks after vaccination (mean CD4+ T cell count 476.9) |
Participants with prior infection with SAR-CoV-2 were excluded |
Neutralization (surrogate neutralization assay—Perkin Elmer) RDB binding antibody (ELISA) Lymphocyte phenotyping (Flow cytometry)
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Inactivated whole virus vaccine is safe and capable of inducing neutralizing antibody responses in PLWH receiving ART and with a CD4+ T cell count of >200 CD3+, CD4+, CD8+ T Cell counts of PLWH decreased following vaccination but did not lead to clinical adverse events |
