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1.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-325065

ABSTRACT

Background: Many Pre-exposure prophylaxis (PrEP) users have difficulty attending the quarterly facility-based HIV testing, which leads to the potential risk of drug resistance in the context of breakthrough infection with low drug compliance. We explored the acceptance of HIV self-testing (HIVST) service among PrEP recipients. Methods: : MSM were recruited for the PrEP demonstration in four major cities in China from December 2018 to September 2019, provided with regimens of both daily and on-demand PrEP. Facility-based HIV testing was provided quarterly at clinic visits. Previous HIV testing history and acceptance of free HIVST kits to use between each quarterly clinic visit was collected. Correlates of levels of acceptance were analysed using multivariable ordinal logistic regression. Results: : We recruited 1,222 MSM. among which 48.5% preferred daily PrEP and 51.5% preferred on-demand PrEP. There was 26.8% (321/1222) had never been to any facility-based HIV testing previously, and the self-reported major reason was that they had already routinely used HIVST. A quarter of the participants (74.5%, 910/1222) had used HIVST previously. There were 1184 MSM (96.9%) accepted to use HIVST between each quarterly clinic visits during PrEP usage, composing 947 ( 77.5%) very willing to, 237(19.4%)willing to, 29 (2.4%) unwilling to, and 9 (0.7%) very unwilling to. Participants preferred daily PrEP (vs. on-demand PrEP, aOR=1.8, 95% CI:1.3-2.4) and had less than 2 times of facility-based HIV testing in the past year (vs. ³2, aOR=1.4,95% CI:1.1-1.9) were more likely to have higher level of acceptance of HIVST. Conclusions: : MSM had high acceptance of HIVST, especially among those preferred daily PrEP and with less facility-based HIV testing in the previous year. Offering HIVST services PrEP recipients is feasible and necessary. Above result is of great significance for promoting HIVST among PrEP users during COVID-19, improving awareness of their HIV infection status and ensuring compliance with medication. Future study should exam the impact of HIVST on HIV testing frequency among PrEP users. Trial registration: ChiCTR1800020374 on 27 th Dec 2018. http://www.chictr.org.cn/searchproj.aspx

4.
Lancet ; 396(10249): 479-488, 2020 08 15.
Article in English | MEDLINE | ID: covidwho-666142

ABSTRACT

BACKGROUND: This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study. METHODS: This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 1011 viral particles per mL or 5 × 1010 viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389. FINDINGS: 603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1 × 1011 viral particles n=253; 5 × 1010 viral particles n=129) or placebo (n=126). In the 1 × 1011 and 5 × 1010 viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2-749·2) and 571·0 (467·6-697·3), with seroconversion rates at 96% (95% CI 93-98) and 97% (92-99), respectively, at day 28. Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 1011 and 5 × 1010 viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post vaccination were observed in 227 (90%, 95% CI 85-93) of 253 and 113 (88%, 81-92) of 129 participants in the 1 × 1011 and 5 × 1010 viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1 × 1011 and 5 × 1010 viral particles dose groups, respectively. Severe adverse reactions were reported by 24 (9%) participants in the 1 × 1011 viral particles dose group and one (1%) participant in the 5 × 1010 viral particles dose group. No serious adverse reactions were documented. INTERPRETATION: The Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunisation. FUNDING: National Key R&D Programme of China, National Science and Technology Major Project, and CanSino Biologics.


Subject(s)
Betacoronavirus/immunology , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/adverse effects , Viral Vaccines/immunology , Adenoviridae , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19 , COVID-19 Vaccines , China , Coronavirus Infections/immunology , Double-Blind Method , Female , Genetic Vectors , Humans , Male , Middle Aged , SARS-CoV-2 , Spike Glycoprotein, Coronavirus/immunology , T-Lymphocytes/immunology , Viral Vaccines/administration & dosage , Young Adult
5.
Lancet ; 395(10240): 1845-1854, 2020 06 13.
Article in English | MEDLINE | ID: covidwho-342974

ABSTRACT

BACKGROUND: A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain. METHODS: We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 1010, 1 × 1011, and 1·5 × 1011 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127. FINDINGS: Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination. INTERPRETATION: The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation. FUNDING: National Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.


Subject(s)
Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/administration & dosage , Adenoviridae , Adolescent , Adult , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Betacoronavirus , COVID-19 , COVID-19 Vaccines , China , Enzyme-Linked Immunosorbent Assay , Female , Humans , Immunity, Cellular , Immunity, Humoral , Injections, Intramuscular , Male , Middle Aged , SARS-CoV-2 , T-Lymphocytes/immunology , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/therapeutic use , Viral Vaccines/adverse effects , Viral Vaccines/therapeutic use , Young Adult
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