Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials.

Combination of waning immunity and lower effectiveness against new SARS-CoV-2 variants of approved COVID-19 vaccines necessitates new vaccines. We evaluated two doses, 28 days apart, of ARCT-154, a self-amplifying mRNA COVID-19 vaccine, compared with saline placebo in an integrated phase 1/2/3a/3b controlled, observer-blind trial in Vietnamese adults (ClinicalTrial.gov identifier: NCT05012943). Primary safety and reactogenicity outcomes were unsolicited adverse events (AE) 28 days after each dose, solicited local and systemic AE 7 days after each dose, and serious AEs throughout the study. Primary immunogenicity outcome was the immune response as neutralizing antibodies 28 days after the second dose. Efficacy against COVID-19 was assessed as primary and secondary outcomes in phase 3b. ARCT-154 was well tolerated with generally mild-moderate transient AEs. Four weeks after the second dose 94.1% (95% CI: 92.1-95.8) of vaccinees seroconverted for neutralizing antibodies, with a geometric mean-fold rise from baseline of 14.5 (95% CI: 13.6-15.5). Of 640 cases of confirmed COVID-19 eligible for efficacy analysis most were due to the Delta (B.1.617.2) variant. Efficacy of ARCT-154 was 56.6% (95% CI: 48.7- 63.3) against any COVID-19, and 95.3% (80.5-98.9) against severe COVID-19. ARCT-154 vaccination is well tolerated, immunogenic and efficacious, particularly against severe COVID-19 disease.

Outbreak of Sexually Transmitted Nongroupable Neisseria meningitidis-Associated Urethritis, Vietnam.

We report on an outbreak of nongroupable Neisseria meningitidis-associated urethritis, primarily among men who have sex with men in southern Vietnam. Nearly 50% of N. meningitidis isolates were resistant to ciprofloxacin. This emerging pathogen should be considered in the differential diagnosis and management of urethritis.

Seroprevalence of SARS-CoV-2 Neutralizing Antibodies among Blood Donors in Ho Chi Minh City, Vietnam, August-November 2020.

Relatively little is known about the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibodies and COVID-19-related behaviors in the general population in Vietnam, where the first case of COVID-19 was detected on January 22, 2020. We surveyed a group of 885 blood donors at community blood donation sessions in Ho Chi Minh City from August 27 to November 7, 2020. Blood was collected to test for SARS-CoV-2 IgG antibodies using the plaque reduction neutralization test. We adjusted the seroprevalence by weight for ages 18 to 59 years old obtained from the 2019 population census. The weighted seroprevalence estimate for SARS-CoV-2 neutralizing IgG antibodies was 0.20% (95% CI, 0.05-0.81). Reports of usually or always using a mask in public places were observed at high levels of 28.6% and 67.5%, respectively. The percentages of usually or always washing hands with soap or disinfecting with hand sanitizer after touching items in public places were 48.0% and 37.6%, respectively. Although our findings suggest undocumented exposure to the virus, the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors was low in this city.

Association of public health interventions and COVID-19 incidence in Vietnam, January to December 2020.

BACKGROUND: Vietnam implemented various public health interventions such as contact tracing and testing, mandatory quarantine, and lockdowns in response to coronavirus disease 2019 (COVID-19). However, the effects of these measures on the epidemic remain unclear. METHODS: This article describes the public health interventions in relation to COVID-19 incidence. Maximum likelihood estimations were used to assess containment delays (time between symptom onset and start of isolation) and multivariable regression was employed to identify associated factors between interventions and COVID-19 incidence. The effective reproductive numbers (Rt) were calculated based on transmission pairs. RESULTS: Interventions were introduced periodically in response to the epidemic. Overall, 817 (55.4%) among 1474 COVID-19 cases were imported. Based on a serial interval of 8.72 ± 5.65 days, it was estimated that Rt decreased to below 1 (lowest at 0.02, 95% CI 0-0.12) during periods of strict border control and contact tracing, and increased ahead of new clusters. The main method to detect cases shifted over time from passive notification to active case-finding at immigration or in lockdown areas, with containment delays showing significant differences between modes of case detection. CONCLUSIONS: A combination of early, strict, and consistently implemented interventions is crucial to control COVID-19. Low-middle income countries with limited capacity can contain COVID-19 successfully using non-pharmaceutical interventions.

An Evaluation of the Rabies Surveillance in Southern Vietnam.

Introduction: Rabies is endemic in Vietnam and has been a statutory notifiable infectious disease since 1998. We, herein, assessed the performance of rabies surveillance in Southern Vietnam and identified areas for improvement. Materials and Methods: We analyzed data on human rabies cases reported during 1991-2018. We adapted guidelines from the U.S. Centers for Disease Control and Prevention to evaluate attributes of surveillance. Between June and November 2018, we interviewed a total of 145 staff from hospitals, preventive medicine centers, and animal health offices at provincial and district levels in five southern provinces. Results: Between 2009 and 2018, an average of nine cases of human rabies (range: 4-20 cases) was reported annually in Southern Vietnam, representing an incidence of 2.7 cases per 10 million population. The highest incidence was observed in 2018 (5.5 cases per 10 million population). Survey data suggested that only 24% (13/53) of participants agreed that the monthly report template was easy to complete and that 42% (23/55) indicated that the change from the paper-based to the electronic case notification systems was easy. Only 7% (2/29) of human rabies cases were reported timely, and 65% (13/20) successfully collected specimens. Approximately 39% (56/144) of staff were aware of turning surveillance data into prevention activities, and 21% (31/145) witnessed data used for strategic program decision making. Conclusions: Although rabies surveillance was quite simple, flexible, and accepted in southern Vietnam, simplifying the report forms, training staff, and improving the timeliness of reporting and data usage are highly recommended for a better implementation of rabies surveillance.

Rotavirus genotype trends from 2013 to 2018 and vaccine effectiveness in southern Vietnam.

OBJECTIVES: Rotavirus (RV) genotypes vary geographically, and this can affect vaccine effectiveness (VE). This study investigated the genotype distribution of RV and explored VE before introducing the RV vaccine to the national immunization programme in Vietnam. METHODS: This hospital-based surveillance study was conducted at Children's Hospital 1, Ho Chi Minh City in 2013-2018. Stool samples and relevant data, including vaccination history, were collected from children aged <5 years who were hospitalized with gastroenteritis. RV was detected using enzyme immunoassays and then genotyped. Children aged ≥6 months were included in the VE analysis. RESULTS: Overall, 5176 children were included in this study. RV was detected in 2421 children (46.8%). RV positivity decreased over the study period and was associated with age, seasonality, location and previous vaccination. Among 1105 RV-positive samples, G3P[8] was the most prevalent genotype (43.1%), followed by G8P[8] (19.7%), G1P[8] (12.9%) and G2P[4] (12.9%). Overall VE was 69.7% [95% confidence interval (CI) 53.3-80.6%] in fully vaccinated children and 58.6% (95% CI 44.1-69.4%) in children who had received at least one dose of RV vaccine. VE was highest for G3P[8] (95% CI 75.1-84.5%) and lowest for G2P[4] (95% CI 32.4-57.2%). CONCLUSIONS: RV remains a major cause of acute gastroenteritis requiring hospitalization in southern Vietnam. The RV vaccine is effective, but its effectiveness varies with RV genotype.

In the interest of public safety: rapid response to the COVID-19 epidemic in Vietnam.

We describe the status of the COVID-19 epidemic in Vietnam, major response successes, factors that prompted implementation of certain public health actions, and the impact of these actions. In addition, information for three case studies is reported, with crucial learnings to inform future response. Findings from this study suggest that as early as 20 January 2020, Vietnam held a national risk assessment, established a national COVID-19 Response Plan and Technical Treatment and Care Guidelines, and prepared public health laboratories to accurately diagnose cases and hospitals to effectively treat patients. The first COVID-19 case was detected on 23 January. As of 30 September, there had been three waves of the COVID-19 epidemic totalling 1095 cases, and resulting in 35 deaths all among people with underlying health conditions. Evidence of potential transmission of SARS-CoV-2 from a commercial passenger flight inbound to Vietnam was reported. This study also highlights the importance of early technical preparedness, strong political commitment, multisectoral and multilevel efforts, increased resourcing and coordination towards an effective COVID-19 response. Controlling outbreaks in settings, such as crowded public places (bars and hospitals), within certain villages and over cities, required early detection, aggressive trace-test-quarantine efforts, a geographically extensive lockdown area and an adoption of several non-pharmaceutical interventions. Many low-income and middle-income countries have experienced their second or third wave of the COVID-19 epidemic, and they can learn from Vietnam's response across the three epidemic waves. Swift governmental action, strict border control measures, effective communication of health promotion measures, widespread community engagement, expanded testing capacity and effective social measures to slow the spread of SARS-CoV-2, are highly important in these locations.

Findings and lessons from establishing Zika virus surveillance in southern Viet Nam, 2016.

OBJECTIVE: To document the evolution and optimization of the Zika virus (ZIKV) disease surveillance system in southern Viet Nam in 2016 and to describe the characteristics of the identified ZIKV-positive cases. METHODS: We established a sentinel surveillance system to monitor ZIKV transmission in eight sites in eight provinces and expanded the system to 71 sites in 20 provinces in southern Viet Nam in 2016. Blood and urine samples from patients who met the case definition at the sentinel sites were tested for ZIKV using real-time reverse transcription polymerase chain reaction at the Pasteur Institute in Ho Chi Minh City (PI-HCMC). We conducted descriptive analysis and mapped the ZIKV-positive cases. RESULTS: In 2016, 2190 specimens from 20 provinces in southern Viet Nam were tested for ZIKV at PI-HCMC; 626 (28.6%), 484 (22.1%), 35 (1.6%) and 1045 (47.7%) tests were conducted in the first, second, third and fourth quarters of the year, respectively. Of these tested specimens, 214 (9.8%) were ZIKV positive with 212 (99.1%) identified in the fourth quarter. In the fourth quarter, the highest positivity rate was those in age groups 30-39 years (30.0%) and 40-59 years (31.6%). Of the 214 ZIKV-positive patients, 210 (98.1%) presented with rash, 194 (90.7%) with fever, 149 (69.6%) with muscle pain, 123 (57.5%) with joint pain and 66 (30.8%) with conjunctivitis. DISCUSSION: The surveillance system for ZIKV disease underwent several phases of optimization in 2016, guided by the most up-to-date local data. Here we demonstrate an adaptable surveillance system that detected ZIKV-positive cases in southern Viet Nam.

Transmission and serotype features of hand foot mouth disease in household contacts in Dong Thap, Vietnam.

BACKGROUND: Hand, foot and mouth disease (HFMD) has emerged as a major public health issue in Vietnam since 2003. We aimed to investigate the household transmission of HFMD and its causative viruses from 150 households in a high incidence province in Vietnam. METHODS: A longitudinal study was conducted in patients presenting to the provincial hospital with a HFMD-like syndrome, along with their household members between April and August 2014 in Dong Thap Province. Each participant was followed up for 2 weeks. We enrolled 150 patients aged under 15 who were clinically diagnosed with HFMD in Dong Thap Hospital, 600 household members, and 581/600 household members completed the study. All participants were interviewed using a standard questionnaire. Throat swabs and blood samples were taken for molecular detection of viruses and assessment of neutralizing antibodies, respectively. Index cases were defined using a clinical case definition, household contact cases were defined using a similar definition applied to the 2 weeks before admission and 2 weeks after discharge of the index case. Characteristics of index cases, household contacts, the attack rate, serotype features and related factors of HFMD were reported. RESULT: Among 150 index cases, 113 were laboratory confirmed: 90/150 were RT-PCR-positive, 101/142 had a ≥ 4-fold increase of neutralizing antibody against Enterovirus A71 (EV-A71), Coxsackievirus (CV) A6 or CV-A16 across the two samples collected. 80/150 (53%) were males, and 45/150 (30%) were under the age of 1. The predominant serotype was CV-A6, identified in 57/87 (65.5%) of the specimens. No deaths were reported. Among 581 household contacts, 148 were laboratory confirmed: 12/581 were RT-PCR-positive, 142/545 had a ≥ 4-fold increase of neutralizing antibodies against EV-A71, CV-A6 or CV-A16; 4 cases experienced HFMD in the past 4 weeks. Attack rate among household contacts was 148/581 (25.5%). In 7/12 (58%) instances, the index and secondary cases were infected with the same serotype. Having a relationship to index case was significantly associated with EV infection. CONCLUSION: The attack rate among household contacts was relatively high (25.5%) in this study and it seems justified to also consider the household setting as an additional target for intervention programs.

Expanding severe acute respiratory infection (SARI) surveillance beyond influenza: The process and data from 1 year of implementation in Vietnam.

BACKGROUND: In 2016, as a component of the Global Health Security Agenda, the Vietnam Ministry of Health expanded its existing influenza sentinel surveillance for severe acute respiratory infections (SARI) to include testing for 7 additional viral respiratory pathogens. This article describes the steps taken to implement expanded SARI surveillance in Vietnam and reports data from 1 year of expanded surveillance. METHODS: The process of expanding the suite of pathogens for routine testing by real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) included laboratory trainings, procurement/distribution of reagents, and strengthening and aligning SARI surveillance epidemiology practices at sentinel sites and regional institutes (RI). RESULTS: Surveillance data showed that of 4003 specimens tested by the RI laboratories, 20.2% (n = 810) were positive for influenza virus. Of the 3193 influenza-negative specimens, 41.8% (n = 1337) were positive for at least 1 non-influenza respiratory virus, of which 16.2% (n = 518), 13.4% (n = 428), and 9.6% (n = 308) tested positive for respiratory syncytial virus, rhinovirus, and adenovirus, respectively. CONCLUSIONS: The Government of Vietnam has demonstrated that expanding respiratory viral surveillance by strengthening and building upon an influenza platform is feasible, efficient, and practical.

Sociodemographic Factors, Sexual Behaviors, and Alcohol and Recreational Drug Use Associated with HIV Among Men Who Have Sex with Men in Southern Vietnam.

A total of 2768 MSM participated in a survey in southern Vietnam. Univariate and multivariate logistic regression analyses were performed to determine predictors of HIV infection. The prevalence of HIV among MSM was 2.6 %. HIV infection was more likely in MSM who were older, had a religion, had engaged in anal sex with a foreigner in the past 12 months, previously or currently used recreational drugs, perceived themselves as likely or very likely to be infected with HIV, and/or were syphilis seropositive. MSM who had ever married, were exclusively or frequently receptive, sometimes consumed alcohol before sex, and/or frequently used condoms during anal sex in the past 3 months were less likely to be infected with HIV. Recreational drug use is strongly associated with HIV infection among MSM in southern Vietnam. HIV interventions among MSM should incorporate health promotion, condom promotion, harm reduction, sexually transmitted infection treatment, and address risk behaviors.

Applying standard epidemiological methods for investigating foodborne disease outbreak in resource-poor settings: lessons from Vietnam.

An outbreak of gastroenteritis occurred among workers of company X after eating lunch prepared by a catering service. Of 430 workers attending the meal, 56 were hospitalized with abdominal pain, diarrhea, vomiting, and nausea, according to the initial report. We conducted an investigation to identify the extent, vehicle, and source of the outbreak. In our case-control study, a case was a worker who attended the meal and who was hospitalized with acute gastroenteritis; controls were randomly selected from non-ill workers. Cases and controls were interviewed using a standard questionnaire. We used logistic regression to calculate adjusted odds ratios for the consumption of food items. Catering service facilities and food handlers working for the service were inspected. Food samples from the catering service were tested at reference laboratories. Of hospitalized cases, 54 fulfilled the case definition, but no stool specimens were collected for laboratory testing. Of four food items served during lunch, only "squash and pork soup" was significantly associated with gastroenteritis, with an adjusted odds ratio of 9.5 (95 % CI 3.2, 27.7). The caterer did not separate cooked from raw foods but used the same counter for both. Cooked foods were kept at room temperature for about 4 h before serving. Four of 14 food handlers were not trained on basic food safety principles and did not have health certificates. Although no microbiological confirmation was obtained, our epidemiological investigation suggested that squash and pork soup caused the outbreak. Hospitals should be instructed to obtain stool specimens from patients with gastroenteritis. Food catering services should be educated in basic food safety measures.

Strengthening global health security capacity--Vietnam demonstration project, 2013.

Over the past decade, Vietnam has successfully responded to global health security (GHS) challenges, including domestic elimination of severe acute respiratory syndrome (SARS) and rapid public health responses to human infections with influenza A(H5N1) virus. However, new threats such as Middle East respiratory syndrome coronavirus (MERS-CoV) and influenza A(H7N9) present continued challenges, reinforcing the need to improve the global capacity to prevent, detect, and respond to public health threats. In June 2012, Vietnam, along with many other nations, obtained a 2-year extension for meeting core surveillance and response requirements of the 2005 International Health Regulations (IHR). During March-September 2013, CDC and the Vietnamese Ministry of Health (MoH) collaborated on a GHS demonstration project to improve public health emergency detection and response capacity. The project aimed to demonstrate, in a short period, that enhancements to Vietnam's health system in surveillance and early detection of and response to diseases and outbreaks could contribute to meeting the IHR core capacities, consistent with the Asia Pacific Strategy for Emerging Diseases. Work focused on enhancements to three interrelated priority areas and included achievements in 1) establishing an emergency operations center (EOC) at the General Department of Preventive Medicine with training of personnel for public health emergency management; 2) improving the nationwide laboratory system, including enhanced testing capability for several priority pathogens (i.e., those in Vietnam most likely to contribute to public health emergencies of international concern); and 3) creating an emergency response information systems platform, including a demonstration of real-time reporting capability. Lessons learned included awareness that integrated functions within the health system for GHS require careful planning, stakeholder buy-in, and intradepartmental and interdepartmental coordination and communication.

A cluster of cholera among patients in a Vietnamese district hospital in 2010.

On July 20, 2010, three cases of cholera were reported from a district hospital in Ca Mau province, Vietnam. We investigated the likely source and mode of transmission of the outbreak. All hospitals in the province were requested to notify cases of acute watery diarrhoea. Epidemiological, clinical, and laboratory data were collected. Between July 12 and 22, seven cases with positive culture for Vibrio cholera were identified. Six cases were epidemiologically linked to the index case. Basic infection control practices were not in place at the hospital. Clinicians and public health staff should consider the possibility of nosocomial cholera transmission even in non-endemic areas.

Acute allergic reactions in Vietnamese children after drinking a new milk product.

In early October 2009, pediatricians in hospitals in Ho Chi Minh City (HCMC) reported an unusual increase in the number of children presenting with an acute onset of itchy rash and some with breathing difficulties shortly after drinking milk products. The pediatricians considered the illness to be an allergic reaction to milk. The objective of our investigation was to identify the cause of this acute illness. Following early case reports, all hospitals in HCMC were requested to report cases of this illness. Parents were advised to take children with symptoms to a hospital immediately. A case-series was conducted to generate hypotheses on the possible causes of the illness and was followed by a case-control study to test the hypothesis. Parents of all cases and controls were interviewed face-to-face. The association between food items and the allergy was tested using conditional logistics regression. From 9 to 28 October 2009, 19 cases fulfilled the case definition, and 16 of the 17 cases included in the study had consumed milk supplemented with galacto-oligosaccharides (GOS) shortly before the onset of illness. Fifty age-matched, neighborhood controls were enrolled into the case control study. Of the 30 food items consumed by study participants in the preceding 24 h, only the odds ratio (OR) of milk supplemented with GOS was statistically significant: OR=34.0 (95% CI=3.9, 294.8). Laboratory tests of this milk product did not reveal any unusual properties, chemicals, or other toxic substances. This is the first report of an acute allergic reaction to fresh milk supplemented with GOS. However, the specific allergen in this product was not identified. Further cases were not reported once this product was withdrawn from sale. Vietnam's food safety authorities should expand laboratory capacity to detect allergens in food products.