Safety and Immunogenicity of SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901 in People Living with HIV
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Abstract
Objectives
To provide data on the immune response to COVID-19 vaccines in people living with HIV (PWH), MVC-COV1901, a recombinant protein vaccine containing S-2P protein adjuvanted with CpG 1018 and aluminium hydroxide, was assessed.
Methods
A total of 57 PWH of ≥ 20 years of age who are on stable antiretroviral therapy and with CD4 + T cell ≥ 350 cells/mm 3 and HIV viral load < 10 3 copies/ml were compared with 882 HIV-negative participants. Participants received 2 doses of MVC-COV1901 28 days apart. Safety and the immunogenicity were evaluated.
Results
No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in people living with HIV (PWH) and comparators, respectively, 28 days after second dose. The geometric mean titers (GMTs) (95% confidence interval [CI]) against wild type SARS-CoV-2 virus were 136.62 IU/mL (WHO Standardized International Unit) (95% CI 114.3-163.3) and 440.41 IU/mL (95% CI 421.3-460.4), for PWH and control groups, respectively, after adjusting for sex, age, BMI category, and comorbidity, and the adjusted GMT ratio of comparator/PWH was 3.22 (95% CI 2.6-4.1). A higher CD4/CD8 ratio was associated with a higher GMT (R=0.27, p=0.039).
Conclusions
MVC-COV1901 has shown robust safety but weaker immunogenicity responses in PWH. As a result, a third dose or booster doses of MVC-COV1901 may be appropriate for PWH.
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SciScore for 10.1101/2021.12.08.21267439: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication Authentication: The detection and characterization of neutralizing antibodies were performed by central laboratories using validated pseudovirus and/or live virus neutralization assays. Table 2: Resources
Antibodies Sentences Resources 19 To measure neutralizing antibody titers, wildtype SARS-CoV-2, Taiwan CDC strain number 4 (hCoV-19/ Taiwan/4/2020; Global Initiative on Sharing All Influenza Data accession ID EPI_ISL_411927), was titrated to calculate the 50% tissue culture infective dose (TCID50). TCID50suggested: None… SciScore for 10.1101/2021.12.08.21267439: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication Authentication: The detection and characterization of neutralizing antibodies were performed by central laboratories using validated pseudovirus and/or live virus neutralization assays. Table 2: Resources
Antibodies Sentences Resources 19 To measure neutralizing antibody titers, wildtype SARS-CoV-2, Taiwan CDC strain number 4 (hCoV-19/ Taiwan/4/2020; Global Initiative on Sharing All Influenza Data accession ID EPI_ISL_411927), was titrated to calculate the 50% tissue culture infective dose (TCID50). TCID50suggested: NoneExperimental Models: Cell Lines Sentences Resources Vero E6 cells were seeded in 96-well plates (at 1.2×10□ cells per well) and incubated. Vero E6suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Despite the insights generated by our study, some limitations to interpretation may exist. First, the sample size in the PWH group was relatively small. Furthermore, all PWH were on stable ART and had CD4+ T cell counts greater than 350 cells/mm3 and HIV viral load less than 1000 copies/ml. Thus, extrapolation to people with HIV with lower CD4 counts, or without suppressed HIV viral loads is not suggested. Second, our study was initiated when SARS-CoV-2 was not endemic in Taiwan, and the low viral transmission rate made it difficult to ascertain the efficacy of the vaccine as an exploratory endpoint. Specifically, low levels of 1% of neutralizing antibody titer were detected both at baseline and on Day 57 in the placebo group, suggesting that COVID-19 was rare and natural infection had not boosted the neutralizing antibody titers. 19 Third, the short duration of the follow-up period in this study did not allow for assessing the durability of immune responses after Day 57. Fourth, although Th1-skewed immune responses had been demonstrated in the phase I MVC-COV1901 study,18 the T-cell responses to the vaccine among PWH were not assessed in this study. Finally, neutralization activities for other SARS-COV2 strains such as Alpha, Beta, Delta, Gamma, and Omicron variants, were not tested and cross-reactivity against emerging Variant of Concerns remains unknown. In conclusion, this report describes a good safety profile but weaker immunogenicity of MCV-COV1901 in PWH, especially i...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04695652 Active, not recruiting A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in … Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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