Drug Database
HE

hepatitis A vaccine (Havisure)

✓ Approved

Indian Immunologicals · Vaccine · Vaccine

What is hepatitis A vaccine?

hepatitis A vaccine is a vaccine developed by Indian Immunologicals. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesHavisure
CompanyIndian Immunologicals
Drug ClassVaccine, Large Molecules
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Indian Immunologicals

Therapeutic Indications

hepatitis A vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresAntiviral prophylaxis✓ Approved

Related Research Articles

PubMedJournal of the International AIDS Society2026-07-25

Vaccination Coverage and Prevention Counselling for Vaccine-Preventable STIs Among HIV PrEP Users in São Paulo, Brazil: A Retrospective Cohort Study.

Rapozo Marjorie Marini MM, Lara Amanda Nazareth AN, Passarelli Victor Cabelho VC, Ramos Laísa Rivas Dapousa LRD et al.

HIV pre-exposure prophylaxis (PrEP) users may be disproportionately vulnerable to sexually transmitted infections (STIs) in general, including several that are vaccine-preventable. Understanding immunization patterns in this population is, therefore, crucial. However, data on vaccination coverage among Brazilian PrEP users remains limited. We conducted a retrospective single-centre study of adults using HIV PrEP at an STI clinic in São Paulo, Brazil, between 2017 and 2024, to assess vaccination adequacy for vaccine-preventable STIs among PrEP users, as well as other STI prevention measures during follow-up. Demographic characteristics, substance use, STI history and vaccination status for hepatitis A (HAV), hepatitis B (HBV), human papillomavirus (HPV) and MPox were extracted from medical records, immunization registries and laboratory results, and descriptive analyses were performed. Among 190 participants (median age: 36 years), 89.5% were gay or other men who have sex with men (MSM). Over a mean follow-up period of 45 months, complete vaccination coverage was observed in 97.7% for HBV, 49.5% for HAV, 24.2% for HPV and 1.6% for MPox. Despite documented prior vaccination, a proportion of participants remained susceptible to HAV (16.3%) and HBV (2.3%). Furthermore, a substantial proportion of participants (32.1% for HAV, 53.7% for HPV and 81.0% for MPox) had neither a documented vaccination status nor a provider recommendation for vaccination recorded in their medical charts. HPV- and MPox-related clinical lesions were documented in 17.9% and 2.1% of participants, respectively. Notable gaps in immunization against preventable STIs were observed in this PrEP cohort in São Paulo, Brazil. While HBV coverage was high, uptake of HAV, HPV and MPox vaccines was low. Addressing these gaps in our cohort requires transitioning from mere provider recommendations to structural public health policies. Implementing on-site vaccine administration within PrEP services, integrating immunization into STI screening, expanding free access and addressing key vulnerabilities are critical steps to eliminate structural barriers and reduce the STI burden.

PMID 42499158
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PubMedOpen forum infectious diseases2026-07-25

Prevalence of Hepatitis B Coinfection in People With HIV by Birth-Year Cohort.

Lee So Jeong SJ, Verinumbe Tarfa T, Lesko Catherine R CR, Fojo Anthony A et al.

Availability of the hepatitis B virus (HBV) vaccine in the United States since 1982 and recommendations for universal/catch-up vaccination of infants and children since the 1990s may be associated with lower HBV prevalence among people with human immunodeficiency virus (HIV; PWH) born after 1980. Active HBV infection prevalence, defined as the proportion of patients with a positive hepatitis B surface antigen result, was assessed among PWH at entry into a clinical cohort. Patients were categorized into birth-year cohorts of 1940-1959, 1960-1979, or 1980-1999 and then further dichotomized into pre- and post-1980 birth-year cohorts. Log binomial regression was used to assess the association of birth-year cohort with hepatitis B surface antigen positivity, adjusting for race/ethnicity, HIV infection risk factor, baseline HIV viral load and CD4+ cell count, HBV active therapy, and year of/age at cohort entry. Among 5598 PWH, most were male (67%) and Black (77%), with a mean age (SD) of 39.7 (9.6) years at cohort entry. Approximately a third of the participants (30%) identified as men who have sex with men, and 39% reported a history of injection drug use. At cohort entry, the majority had a CD4+ cell count <350/µL and a viral load >1000 copies/mL. The HBV prevalence was 6.7% overall but varied by birth-year cohort: 6.2% for 1940-1959, 7.9% for 1960-1979, and 2.6% for 1980-1999. The risk of HBV infection was lower in the post-1980 than in the pre-1980 cohort (adjusted prevalence ratio, 0.19 [95% confidence interval, .09- .42]). PWH born after 1980 had a lower prevalence of HBV coinfection than those born before 1980, supporting the potential impact of universal childhood HBV vaccination.

PMID 42500124
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PubMedJournal of the International AIDS Society2026-07-25

Behavioural and Structural Determinants of Mpox Vaccine Awareness and Uptake Among People With HIV in the Dominican Republic: A Cross-Sectional Study.

Paulino-Ramirez Robert R, Matias Wilfredo R WR, Chaumette Alexandre A, Lora-Rodríguez Hector H et al.

Mpox disproportionately affects people with HIV (PWH), yet little is known about mpox vaccine awareness and uptake in low- and middle-income countries. We evaluated mpox-related knowledge, attitudes and practices (KAP) among PWH in the Dominican Republic to identify determinants of vaccine awareness and uptake. We conducted a cross-sectional online survey of 98 PWH recruited through HIV clinics, community-based organizations and social networks (January-May 2025). The questionnaire assessed sociodemographic characteristics, mpox-related KAP, structural barriers and vaccination status. Univariable and multivariable logistic regression were used to examine factors associated with mpox vaccine awareness. Half of the participants (49/98) were aware of the mpox vaccine. Individuals aged 31-40 years had significantly lower odds of awareness compared with those aged 21-30 years. Despite high levels of formal education, 79% rated their mpox knowledge as low, and most perceived minimal personal risk. Among participants aware of the vaccine, 71% had been vaccinated. Structural barriers, including inconvenient site locations and logistical challenges, were frequently reported, even among vaccinated individuals, indicating that access limitations rather than hesitancy were the dominant constraints. Trust in vaccinating organizations was high overall, and healthcare providers and community organizations were the primary sources of vaccine information. Peer and community influence emerged as notable facilitators of uptake, while lack of reliable information and concerns about vaccine safety contributed to hesitancy. Mpox vaccine awareness among PWH in the Dominican Republic was low, but willingness to vaccinate was high when individuals were informed and able to access services. Strengthening mpox preparedness will require expanding accessible vaccination sites, improving disease-specific health literacy, and leveraging trusted community and clinical networks. Integrating mpox vaccination into routine HIV care delivery and enhancing community-led outreach may substantially improve uptake in this and similar low-middle income countries (LMIC) settings.

PMID 42499164
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PubMedPneumonia (Nathan Qld.)2026-07-25

Pneumococcal pneumonia in adults - re-emergence of vaccine serotypes: a prospective multicenter cohort study in Germany, 2020-2023.

Bahrs Christina C, Rose Norman N, Barten-Neiner Grit G, Fleischmann-Struzek Carolin C et al.

The main burden of non-invasive pneumococcal diseases in adults is largely due to community-acquired pneumonia (CAP). This study aimed to investigate the distribution and dynamics of pneumococcal vaccine serotypes and to determine the proportion of CAP cases attributable to serotypes covered by 13-valent conjugate vaccine (PCV13), the 20-valent conjugate vaccine (PCV20), and the 23-valent polysaccharide vaccine (PPV23) among adults in Germany from 2020 to 2023. In this prospective multicenter cohort study, we analyzed all adult patients with CAP enrolled between January 1, 2020, and December 31, 2023, at 26 centers in Germany who provided urine samples for serotype-specific urine antigen detection (SSUAD) testing. Annual trends of pneumococcal vaccine serotypes from 2020 to 2023 were calculated for all patients and patient groups at risk using cluster-robust generalized linear models with heteroscedasticity-consistent standard errors. Of the 2,028 patients with all-cause CAP, 1,504 (1,008 patients aged ≥ 60 years, 373 younger patients with at least one comorbidity) had urine samples analyzed with SSUAD tests. Overall proportion of vaccine-type pneumococcal pneumonia among all-cause CAP for PCV13, PCV20, and PPV23 serotypes was 5.41% (95% CI 4.12-7.06%), 8.11% (95% CI 6.35-10.31%), and 8.31% (95% CI 6.27-10.93%), and serotype 3 was the most prevalent serotype (52 cases). Among patients aged ≥ 60 years, an increasing annual trend was observed for serotype 3 (OR 1.84, 95% CI 1.01-2.67), PCV13 (OR 1.89, 95% CI 0.89-2.89), PCV20 (OR 1.57, 95% CI 0.99-2.14), and PPV23 serotypes (OR 1.47, 1.04-1.91). The findings demonstrate that vaccine serotypes, particularly serotype 3, continued to circulate and reemerged among older adults with CAP in Germany.

PMID 42498972
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PubMedHospital pharmacy2026-07-25

Distribution and Characteristics of Vaccine Adverse Events: Analysis of Over 2 Million Individual Case Safety Reports.

Castellana Eleonora E, Chiappetta Maria Rachele MR

To describe the distribution and characteristics of adverse events following immunization (AEFI) using a large US pharmacovigilance database. A retrospective descriptive analysis of Individual Case Safety Reports (ICSRs) from the FDA AEMS database (January 2017-March 2026) was conducted. Reports were analyzed by vaccine type, adverse event terms, demographics, reporting year, and reporter category. A total of 2 169 603 ICSRs were identified, with 44.0% classified as serious. COVID-19 vaccines accounted for 78.4% of reports, reflecting mass vaccination campaigns. The most frequently reported events were headache (12.8%), pyrexia (11.8%), and fatigue (11.1%), predominantly non-serious and consistent with known reactogenicity profiles. Reporting peaked in 2021 (48.8%). Females accounted for 60.6% of reports. Non-COVID vaccines contributed substantially fewer reports. Most vaccine-associated adverse events were mild and expected. Findings support a favorable benefit-risk profile and highlight the importance of continuous pharmacovigilance systems for vaccine safety monitoring.

PMID 42500260
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PubMedArchives of virology2026-07-25

HBV PreS/S gene mutations in patients with chronic hepatitis B.

Çakal Bülent B, Çavuş Bilger B, Atasoy Alp A, Bulakçı Mesut M et al.

Variants in the hepatitis B virus (HBV) PreS/S gene have been suggested to contribute to the development of progressive liver disease. This study aimed to evaluate the association between HBV PreS/S variations and liver histopathology in patients with chronic hepatitis B. A total of 109 patients under clinical follow-up for chronic hepatitis B were included. The HBV PreS/S gene was amplified by PCR and sequenced using the Sanger method. Amino acid substitutions, nonsense mutations, and deletions were analyzed in relation to liver fibrosis stage. Overall, 58 of 389 amino acid sites (14.9%) in the HBV PreS/S gene showed substitutions, with the highest mutation rate observed in the PreS2 region (27.27%). Mutations L54P (PreS1), F130L/S (PreS2), and S207R/N/I/T and I208T (S gene) were significantly more frequent in patients with advanced fibrosis (F ≥ 3) (p < 0.05). Multivariable analysis identified S207R/N/I/T as an independent risk factor for liver fibrosis. Patients with PreS2 mutations had higher fibrosis scores (p < 0.05). The S207R/N/I/T mutation in the C-terminal region of the HBV S protein is independently associated with liver fibrosis, while PreS2 mutations may contribute to fibrosis progression in chronic hepatitis B.

PMID 42498832
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