Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial.

Evolution of SARS-CoV-2 variants emphasizes the need for multivalent vaccines capable of simultaneously targeting multiple strains. SCTV01E is a tetravalent COVID-19 vaccine derived from the spike protein of SARS-CoV-2 variants Alpha, Beta, Delta, and Omicron BA.1. In this double-blinded placebo-controlled pivotal efficacy trial (NCT05308576), the primary endpoint was vaccine efficacy (VE) against COVID-19 seven days post-vaccination in individuals without recent infection. Other endpoints included evaluating safety, immunogenicity, and the VE against all SARS-CoV-2 infections in individuals meeting the study criteria. Between December 26, 2022, and January 15, 2023, 9,223 individuals were randomized at a 1:1 ratio to receive SCTV01E or a placebo. SCTV01E showed a VE of 69.4% (95% CI: 50.6, 81.0) 7 days post-vaccination, with 75 cases in the placebo group and 23 in the SCTV01E group for the primary endpoint. VEs were 79.7% (95% CI: 51.0, 91.6) and 82.4% (95% CI: 57.9, 92.6), respectively, for preventing symptomatic infection and all SARS-CoV-2 infections 14 days post-vaccination. SCTV01E elicited a 25.0-fold higher neutralizing antibody response against Omicron BA.5 28 days post-vaccination compared to placebo. Reactogenicity was generally mild and transient, with no reported vaccine-related SAE, adverse events of special interest (AESI), or deaths. The trial aligned with the shift from dominant variants BA.5 and BF.7 to XBB, suggesting SCTV01E as a potential vaccine alternative effective against present and future variants.

Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel-controlled, non-inferiority, single-centre study.

BACKGROUND: Heterologous booster immunisation with orally administered aerosolised Ad5-nCoV vaccine (AAd5) has been shown to be safe and highly immunogenic in adults. Here, we aimed to assess the safety and immunogenicity of heterologous booster immunisation with orally administered AAd5 in children and adolescents aged 6-17 years who had received two doses of inactivated vaccine (BBIBP-CorV or CoronaVac). METHODS: We did a randomised, open-label, parallel-controlled, non-inferiority study to assess the safety and immunogenicity of heterologous booster immunisation with AAd5 (0·1 mL) or intramuscular Ad5-nCoV vaccine (IMAd5; 0·3 mL) and homologous booster immunisation with inactivated vaccine (BBIBP-CorV or CoronaVac; 0·5 mL) in children (aged 6-12 years) and adolescents (aged 13-17 years) who had received two doses of inactivated vaccine at least 3 months earlier in Hunan, China. Children and adolescents who were previously immunised with two-dose BBIBP-CorV or CoronaVac were recruited for eligibility screening at least 3 months after the second dose. A stratified block method was used for randomisation, and participants were stratified by age and randomly assigned (3:1:1) to receive AAd5, IMAd5, or inactivated vaccine. The study staff and participants were not masked to treatment allocation. Laboratory and statistical staff were masked during the study. In this interim analysis, adverse events within 14 days and geometric mean titre (GMT) of serum neutralising antibodies on day 28 after the booster vaccination, based on the per-protocol population, were used as the primary outcomes. The analysis of non-inferiority was based on comparison using a one-sided 97·5% CI with a non-inferiority margin of 0·67. This study was registered at ClinicalTrials.gov, NCT05330871, and is ongoing. FINDINGS: Between April 17 and May 28, 2022, 436 participants were screened and 360 were enrolled: 220 received AAd5, 70 received IMAd5, and 70 received inactivated vaccine. Within 14 days after booster vaccination, vaccine-related adverse reactions were reported: 35 adverse events (in 13 [12%] of 110 children and 22 [20%] of 110 adolescents) in 220 individuals in the AAd5 group, 35 (in 18 [51%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 13 (in five [14%] of 35 children and eight [23%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. Solicited adverse reactions were also reported: 34 (13 [12%] of 110 children and 21 [10%] of 110 adolescents) in 220 individuals in the AAd5 group, 34 (17 [49%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 12 (five [14%] of 35 children and seven [20%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. The GMTs of neutralising antibodies against ancestral SARS-CoV-2 Wuhan-Hu-1 (Pango lineage B) in the AAd5 group were significantly higher than the GMTs in the inactivated vaccine group (adjusted GMT ratio 10·2 [95% CI 8·0-13·1]; p<0·0001). INTERPRETATION: Our study shows that a heterologous booster with AAd5 is safe and highly immunogenic against ancestral SARS-CoV-2 Wuhan-Hu-1 in children and adolescents. FUNDING: National Key R&D Program of China.

Perceived Facilitators and Barriers regarding Partner Notification in People Living With HIV in Hunan, China: A Qualitative Study From the Patient Perspective.

Consensus has been reached about the important role of partner notification (PN) for HIV prevention and control programs. We used a qualitative study to explore facilitators of and barriers to PN to understand reasons for disclosure and nondisclosure by people living with HIV in China. Our main goal was to identify information related to PN that may be unique to the Chinese cultural context. Of 41 participants who were interviewed, 33 had disclosed their HIV status to sexual partners. Facilitators for PN included preserving the integrity of the partnership, social support, and potential benefits of notification; barriers included perceived discrimination/stigma, possible negative consequences, and safety concerns. Participant physical health conditions, strength of the relationship, and concordant identification were found to be conditional factors of PN. Our findings provide information for a better understanding of PN in Chinese culture and offer a reference for developing more specific strategies to facilitate PN.

Psychometric testing of the consequences of an HIV disclosure instrument in Mandarin: a cross-sectional study of persons living with HIV in Hunan, China.

PURPOSE: This study aimed to examine the psychometric properties of a Mandarin-language version of an instrument that assesses the Consequences of HIV Disclosure (CoHD). PATIENTS AND METHODS: The original CoHD instrument developed by Serovich was translated into Mandarin and administered to a random sample of 184 persons living with HIV (PLWH) using face-to-face and structured interviews. The CoHD instrument required respondents to rate the importance of eight costs (eg, might lose the relationship) and ten rewards (eg, would bring us closer) in their decision about whether to self-disclose their HIV status. The participants were directed to respond with respect to a current (or hypothetical) sexual partner. RESULTS: Internal consistency was acceptable (Cronbach's α for the overall scale 0.82, costs 0.71, and rewards 0.86), as was stability (test-retest reliability overall 0.74, cost 0.63, and rewards 0.82). The CVI for the scale was 0.83, with items rated by subject experts ranging from 0.80 to 1.0. To determine structural validity, exploratory factor analysis extracted two subscales consistent with the original CoHD subscales. The Mandarin CoHD scores were significantly correlated with disclosure self-efficacy (indicating convergent validity), but they were unrelated to safer sex efficacy (indicating divergent validity). This criterion was tested by comparing the scores of PLWH who disclosed their HIV status (mean±SD 53.57±9.06) with those who did not disclose it (mean±SD 49.63±7.45); however, the difference was not statistically significant. CONCLUSION: The Mandarin version of the CoHD instrument demonstrates promising psychometric properties when assessing costs and rewards with respect to sexual partner disclosure. This suggests that it might be useful in research on partner notification strategies. In further studies, larger and more diverse samples and an analysis of responses for different disclosure targets are warranted. Moreover, whether the CoHD score is related to the decision of disclosure should be determined.

Factors associated with self-reported unprotected anal intercourse among men who have sex with men in Changsha city of Hunan province, China.

Men who have sex with men (MSM) in China are highly susceptible to HIV infection and HIV prevalence among Chinese MSM is rapidly increasing in recent years. Unprotected anal intercourse (UAI) is a major contributing factor of HIV transmission. This study aims to identify factors associated with UAI among MSM in Changsha city, China. A cross-sectional survey was conducted among 642 MSM in Changsha city from July 2009 to June 2011 via a venue-based sampling method. Data on socio-demographic characteristics, sexual behaviours and utilisation of HIV/AIDS services were collected to determine the associates of UAI in MSM. Among the 642 MSM, 184 (28.7%) reported having UAI with male partners at the last sexual episode. UAI was associated with the venues where MSM met other MSM, and having unprotected sex with female partners at last the sexual episode and in the past six months. In addition, UAI was significant associated with not being exposed to HIV interventions, including free condom, lubricant, HIV testing and counselling, and peer education. MSM who have UAI practice are more likely to have unprotected sex with female; hence, potentially bridging HIV to the general female population. Specific harm-reduction programmes are shown to have significant impacts in reducing UAI and should be scaled up among MSM in China.

Barriers and Potential Improvements for Needle and Syringe Exchange Programs (NSPs) in China: A Qualitative Study from Perspectives of Both Health and Public Security Sectors.

This study explores the acceptability, the barriers to the implementation of needle and syringe exchange programs (NSPs) and the potential improvement strategies in China from the perspectives of governmental health and public security officials. Purposive sampling was used for recruitment of participants who had been involved in NSPs implementation. Semi-Structured individual interviews were conducted in Mandarin to address three aspects of NSPs: (1) participants' attitudes towards NSPs, (2) participants' opinions on the effectiveness and barriers of NSPs, and (3) suggestions for improving the program. Content analysis was used to analyse the translated interview data. A total of 68 participants from 12 Hunan counties were interviewed (34 from each of the Bureau of Health and the Narcotic Division). Both groups recognised the importance and effectiveness of NSPs in HIV prevention, but public security officials regarded NSPs as a temporary intervention in place of punitive measures. Most health officials (32/34) regarded the main barriers to its implementation as administrative and structural, whereas participants from Narcotics Division (n=24) questioned the legitimacy of NSPs and concerned about the poor management of drug users' risk behaviours. Close cooperation between the health and public security sectors, engagement of the drug user community and an enabling policy environment were reportedly to be critical for potential improvements of NSPs in China. Misconceptions about NSPs encourage drug users' addictive behaviour, and an unclear leadership and insufficient support de-motivate the participants from the Bureau of Health and the Narcotics Division to actively support the program implementation.

[Comparison between methods as polling booth survey and face-to-face interview in understanding the high-risk behavior among HIV-positive clients of female sex workers].

OBJECTIVE: Face-to-face interview (FTFI) and polling booth survey (PBS) were applied to compare the high risk behavior among HIV-positive clients of female sex workers (CFSWs). METHODS: This study was conducted in antiretroviral therapy (ART) out-patients centers in Hengyang city, where clients who had been informed on their HIV-positive status for 6 months or longer were recruited. FTFI was first used to tackle on 8 sensitive questions related to sexual behavior, followed by PBS to poke on the same questions. Results from FTFI and PBS were then compared. RESULTS: Compared with FIFI, results in the PBS showed higher proportion of participants who reported "having had history of sexually transmitted diseases before knowing that they were infected with HIV" (40.6% vs. 24.2%) but lower proportions on "frequency of having sex with regular sexual partner less than 4 times per month" and "using condoms consistently with regular sexual partners in past 6 months (44.4% vs. 63.0%)". There were no significant differences in the remaining 5 questions shown in the results from the two methods. CONCLUSION: HIV-positive CFSWs continued to practice unsafe sexual behaviors after knowing their HIV related status. Compared with FTFI, PBS seemed to have revealed higher proportion of unsafe sex behaviors, so as to generated more reliable data. While comparing with PBS, the traditional FTFI might have underestimated the risk behaviors among those HIV-positive CFSWs.

Club Drugs and HIV/STD Infection: An Exploratory Analysis among Men Who Have Sex with Men in Changsha, China.

OBJECTIVE: To evaluate current club drug use and its potential association with the transmission of HIV/STD among Changsha men who have sex with men (MSM). METHOD: A cross-sectional survey was conducted by using self-administered questionnaires including information regarding socio-demographics, club drug use, high-risk behaviors, and HIV/STD infections. Multiple methods including venue-based, peer referral using "snowball" techniques, and internet advertisements were used to recruit study participants. RESULTS: Of the 826 participants, 177 (21.4%) reported that they had used club drugs at some time before or during sex in the past six months. MSM with young age, low education level, and seeking partners through the internet or bars were the main population who used drugs. Poppers were the most common drug used among Changsha MSM. The prevalence of HIV, syphilis, and herpes simplex virus-2 were higher among drug users. There were no significant differences in unprotected sexual intercourse and condom use between drug users and non-users. Compared with non-users, risk behaviors such as group sex, multiple sex partners, and sex with foreigners were more frequent among drug users. CONCLUSION: Club drug use is common among Changsha MSM, and is related to unsafe sex activities and HIV/STD infection. It is necessary to build novel targeted HIV prevention strategies to monitor and reduce club drug use among MSM.

Ability to access community-based needle-syringe programs and injecting behaviors among drug users: a cross-sectional study in Hunan Province, China.

BACKGROUND: Needle-syringe exchange programs (NSPs) have been substantially rolled-out in China since 2002. Limited studies reported effectiveness of NSPs in a Chinese setting. This study aimed to assess the association between accessibility to NSPs and drug-use risk behaviors of IDUs by investigating primary (self-reported) data of IDUs recruited from NSP sites, community settings and mandatory detoxification centers (MDCs) in Hunan province, China. METHODS: A cross-sectional survey was conducted in Hunan province in 2010. IDU recruits participated in a face-to-face interview to provide information related to their ability to access NSPs, demographic characteristics, and injecting behaviors in the past 30 days. RESULTS: Of the total 402 participants, 35%, 14% and 51% participants indicated low, medium and high ability to access NSPs in the past 30 days, respectively. A significantly higher proportion of IDUs (77.3%) from the high-access group reported ≤2 injecting episodes per day compared with medium- (46.3%) and low-access (58.8%) groups. Only 29.0% of high-access IDUs re-used syringes before disposal in the past 30 days, significantly lower than those in the medium- (43.1%) and low-access (41.3%) groups. Reported levels of needle/syringe sharing decreased significantly as the ability to access NSPs increased (16.3%, 12.7% and 2.5% in the low, medium and high access groups, respectively). Ninety percent of IDUs recruited from MDCs had low ability to access NSPs. CONCLUSIONS: Increased NSP accessibility is associated with decreased levels of injecting frequency, repetitive use and sharing of injecting equipment among Chinese IDUs. Mandatory detention of IDUs remains as a major barrier for IDUs to access NSPs in China.