Typbar TCV (typhoid Vi conjugate vaccine) / Bharat Biotech - LARVOL DELTA

Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience. (PubMed, Hum Vaccin Immunother) - "Results established that Typbar TCV® induced significantly higher antibody titer compared to Typhim Vi on days 28 and 90 (p < .001). Thus, Typbar TCV® was studied effectively from 6 months to above 85 years, which is the upper age limit. CTRI Registration number: CTRI/2016/01/006476, CTRI/2024/06/069638."

Clinical • Journal • Infectious Disease

Trivalent Salmonella Conjugate Vaccine (TSCV) (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: University of Maryland, Baltimore | Trial primary completion date: Apr 2025 ➔ Jan 2027 | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date

IAPSM's Position Paper on Typhoid Vaccines for Adult Immunization in India. (PubMed, Indian J Community Med) - "IAPSM suggests routine use of Typbar-TCV™ for adults up to 45 years old in India. The organization also highlights the necessity for post-marketing surveillance of these vaccines, to monitor the long-term safety and effectiveness of various vaccines in different communities. IAPSM encourages members to take front-line efforts in their community health service areas, and finally appeals for the development of vaccines to cover a more extensive range of Salmonella infections so that control over typhoid can be strengthened."

Journal • Infectious Disease

OPTIMAL: Opportunistic Pneumococcal Immunisation Trial in MALnutrition (clinicaltrials.gov) - P4 | N=264 | Not yet recruiting | Sponsor: Nick Fancourt

New P4 trial • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

ZyVac-TCV Bangladesh Study (clinicaltrials.gov) - P3 | N=4000 | Not yet recruiting | Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

New P3 trial • Infectious Disease

Non-inferiority Trial of Locally Manufactured Typhoid Conjugate Vaccine 'Typhocon' in Bangladesh (clinicaltrials.gov) - P1/2 | N=630 | Completed | Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh | Recruiting ➔ Completed

Head-to-Head • Trial completion • Infectious Disease

Results from a Phase III study to assess the safety, immune response, and lot-to-lot consistency of EuTCV single-dose and multi-dose formulation compared to the comparator vaccine Typbar-TCV® in healthy African adults and young children 6 months . (ASTMH 2024) - "In Cohort 3, immunogenicity assessments included typhoid (anti-Vi polysaccharide geometric mean titer and seroconversion rates 28 days and 6 months post-vaccination) and seroconversion rates following measles, rubella, and yellow fever vaccination. We report the results of this Phase III study which will be submitted as part of the PQ dossier."

Clinical • P3 data • Infectious Disease • Measles • Rubella

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Field Effectiveness of a Typhoid Conjugate Vaccine: The 2018 Navi Mumbai Pediatric TCV Campaign. (PubMed, Am J Trop Med Hyg) - "The adjusted odds ratio of typhoid fever among vaccinated children was 0.16 (95% CI: 0.05-0.55), equivalent to a vaccine effectiveness of 83.7% (95% CI: 45.0-95.3). Vaccine effectiveness of Typbar-TCV in this large public sector vaccine introduction was similar to prior randomized controlled trials, providing reassurance to policymakers that TCV effectiveness is robust in a large-scale implementation."

Journal • Infectious Disease • Pediatrics

Longevity of serologic responses following a single dose of typhoid conjugate vaccine among children living with HIV in Pakistan: A prospective cohort study. (PubMed, Vaccine) - "There was a decline in seroconversion after one year of TCV in children living with HIV. The decline was significant in children with severe or advanced HIV disease. A significant decrease in seroconversion rates was observed among children living with HIV following one year of TCV administration."

Journal • Human Immunodeficiency Virus • Infectious Disease

A TLR4 ligand-based adjuvant for promoting the immunogenicity of typhoid subunit vaccines. (PubMed, Front Immunol) - "None of the typhoid Vi Polysaccharide (ViPS) subunit vaccines incorporate adjuvants, and the immunogenicity of ViPS vaccines (e.g. Typbar TCV® and Typhim Vi®) is in part due to associated TLR4 ligands such as endotoxin present in these vaccines. Nevertheless, when adjuvanted with Turbo, poorly immunogenic ViPS induced a robust IgG response in young and adult mice, and this was observed even under antigen-limiting conditions. These data suggest that incorporation of Turbo as an adjuvant will make typhoid vaccines more immunogenic regardless of their intrinsic immunogenicity or conjugation status and maximize the efficacy across all ages."

Journal • Infectious Disease • Tetanus • TLR4

The safety and immunogenicity of a bivalent conjugate vaccine against Salmonella enterica Typhi and Paratyphi A in healthy Indian adults: a phase 1, randomised, active-controlled, double-blind trial. (PubMed, Lancet) - "Sii-PTCV was safe and immunogenic for both typhoid and paratyphoid antigens indicating its potential for providing comprehensive protection against enteric fever."

Journal • P1 data • Infectious Disease • Musculoskeletal Pain • Pain

A randomized controlled, double blinded, non-inferiority trial to evaluate the immunogenicity and safety of locally manufactured typhoid conjugate vaccine among Bangladeshi population (ASTMH 2023) - "Three large Phase III efficacy trials of Typbar-TCV (Vi-polysaccharide conjugated to tetanus toxoid) conducted in Bangladesh, Nepal, and Malawi showed that the Typbar-TCV provides 85, 78, and 84 percent protection in children 9 months to <16 years old, respectively...The findings of this study will be helpful to inform the country's decision-making for the introduction of Typhocon into the routine expanded programme on immunisation in Bangladesh. It will increase the supply of TCVs and meet the demand for vaccines in Bangladesh and the region."

Clinical • Head-to-Head • Late-breaking abstract • Infectious Disease • Tetanus

Long Term Immunogenicity of a Single Dose of Typhoid Conjugate Vaccine in children 6 months to 10 years in Hyderabad Pakistan (ASTMH 2023) - "This study aimed to measure the long-term immune response using ELISA anti-Vi Ig G antibodies over time following immunization with Typbar-TCV in children 6 months-10 years in Hyderabad, Pakistan...Our study shows successful seroconversion (95.8%) 4-6 weeks following a single dose of TCV. Elevated anti-Vi-Ig G antibody titers were maintained above the baseline at 4 years in 438/579 (75.6%) of the cohort."

Clinical • Late-breaking abstract • Infectious Disease

Serologic response using ELISA anti-Vi IgG antibodies at several time points following immunization with Typbar-TCV among HIV infected children in Karachi Pakistan (ASTMH 2023) - "Thus, it can be concluded that the overall seroconversion rates of TCV among HIV-positive children are lower as compared to healthy children. Therefore, the need for a booster dose of TCV should be assessed and administered accordingly amongst immunocompromised patients."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Serologic response using ELISA anti-Vi IgG antibodies at several time points following immunization with Typbar-TCV among HIV infected children in Karachi Pakistan (ASTMH 2023) - "Thus, it can be concluded that the overall seroconversion rates of TCV among HIV-positive children are lower as compared to healthy children. Therefore, the need for a booster dose of TCV should be assessed and administered accordingly amongst immunocompromised patients."

Clinical • Human Immunodeficiency Virus • Infectious Disease • CD4

Immunogenicity and tolerability of different dose schedules of Typhoid Conjugate Vaccine in Nepal (ASTMH 2023) - "In the current study we assessed the immunogenicity of Vi-TT (Typbar TCV, Bharat Biotech International, India) at 9 and 12 months of age and after a booster dose at 15 months, at Patan Hospital, Kathmandu...Vi-TT is immunogenic at both 9 and 12 months of age. The longer interval between doses in the 9-month group was associated with a stronger response to a booster."

Infectious Disease • Novel Coronavirus Disease

The effect of a comprehensive typhoid conjugate vaccine campaign on antimicrobial prescribing in children in Harare, Zimbabwe: a mixed methods study. (PubMed, Lancet Glob Health) - "Non-specific febrile illness caused by confirmed or suspected typhoid is a common cause of antimicrobial use in endemic areas. Although effective in preventing typhoid fever, we were unable to identify any effect of Typbar-TCV on antimicrobial prescribing. Ethnographic research showed the effect of contextual factors on antimicrobial prescribing, including concerns regarding safe water access, appropriate sewage disposal, health-care and diagnostic availability. To realise effects beyond disease burden reduction, holistic approaches addressing these concerns are needed so that the value of vaccines mitigating the effects of antimicrobial use as a driver of antimicrobial resistance is fully achieved."

Journal • Infectious Disease • Mood Disorders • Pediatrics

Coverage survey of typhoid conjugate vaccine among children aged 6 months to 15 years in an urban slum settlement of Lyari Town Karachi, Pakistan. (PubMed, PLoS One) - "The overall immunization coverage rate with TCV was found to be satisfactory. Immunization coverage was comparable among both sexes and the selected union councils but it was relatively low among children in younger age groups."

Journal • Infectious Disease

Retrospective Review of Blood Culture-Confirmed Cases of Enteric Fever in Navi Mumbai, India: 2014-2018. (PubMed, Am J Trop Med Hyg) - "Prior to the implementation of Typbar-TCV typhoid conjugate vaccine (TCV) in a public sector pediatric immunization campaign in Navi Mumbai, India, we conducted a retrospective review of blood culture-confirmed cases of typhoid and paratyphoid fevers to estimate the local burden of disease...Culture positivity was highest in the last months of the dry season (April-June). Our findings indicate a substantial burden of enteric fever in Navi Mumbai and support the importance of TCV immunization campaigns and improved water, sanitation, and hygiene."

Journal • Retrospective data • Review • Infectious Disease • Pediatrics

Trivalent Salmonella Conjugate Vaccine (TSCV) (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: University of Maryland, Baltimore | Not yet recruiting ➔ Recruiting

Enrollment open

A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal. (PubMed, Hum Vaccin Immunother) - "Groups A to C received a single dose (25 μg) of Vi-DT test vaccine from any of the 3 lots, while group D received the comparator, Typbar-TCV®, Vi-tetanus toxoid (Vi-TT) vaccine (25 μg) in 1:1:1:1 ratio and evaluated at 4 weeks postvaccination with 6 months follow-up...Three serious adverse events (1 in Vi-DT; 2 in Vi-TT group) were reported during the 6 months follow-up, none being related to the investigational product. Thus, Vi-DT vaccine is safe, immunogenic, and immunologically non-inferior to Vi-TT when analyzed at 4 weeks postvaccination."

Head-to-Head • Journal • P3 data • Infectious Disease • Tetanus

TyVECO: Effectiveness of a Typhoid Conjugate Vaccine in DRC (clinicaltrials.gov) - P4 | N=48000 | Recruiting | Sponsor: International Vaccine Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Meningococcal Infections • Pediatrics