CLINICAL TRIALS PROFILE FOR TYPHIM VI

All Clinical Trials for TYPHIM VI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00326443 ↗	CVD 909 Vi Prime Boost Study	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2006-02-01	The purpose of this research study is to see if giving a typhoid vaccine by mouth (an experimental vaccine, CVD 909) before giving a vaccine shot (Typhim Vi) will result in a better immune response than giving Typhim Vi vaccine by itself. Another purpose is to see whether CVD 909 is safe. Typhim Vi has been shown to be safe and effective in preventing typhoid fever in older children and adults, but it does not work in children under age 2. Scientists at the University of Maryland think that young children could respond to Typhim Vi if they were given a dose of the other typhoid vaccine by mouth before they are given the Typhim Vi shot. Twenty-eight healthy adult volunteers, ages 18-40 years, will take part in this study. Study participation will last for up to 63 weeks, but most of the study visits will be in the first 6 weeks. Blood samples will be collected approximately 13 times. Four stool samples will be collected. Some volunteers may be followed for an additional 4 years.
NCT02286544 ↗	Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers	Completed	University Hospital, Linkoeping	Phase 1	2014-10-01	Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial infarction and variably recommended in ACS-guidelines, despite very limited data supporting a beneficial effect. Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow achieved with primary PCI can give rise to further damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, transcriptional reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in STE-ACS patients has not previously been studied. ACS is characterized by a systemic inflammation with typical elevations of soluble inflammatory markers as well as changes in white blood cells. The inflammatory reaction might be considered helpful in restoring myocardial tissue structure and function, but on the other hand it might worsen IR-injury by activating various pathological processes. In human experimental studies, Salmonella typhi vaccine has been used to create a standardized model of systemic inflammation and when administered to healthy volunteers the vaccination has not been associated with any adverse events. In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on morbidity and mortality in ACS patients is being investigated. In a substudy of the DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological processes involved. The presented study is an experimental pilot study performed in healthy volunteers with a Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen treatment on biological systems involved in the pathogenesis of IR- injury.
NCT02286544 ↗	Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers	Completed	Karolinska Institutet	Phase 1	2014-10-01	Oxygen treatment is widely used in acutely ill patients. In particular, oxygen treatment is routinely used in acute coronary syndrome (ACS) patients with suspected acute myocardial infarction and variably recommended in ACS-guidelines, despite very limited data supporting a beneficial effect. Immediate re-opening of the acutely occluded infarct-related bloodvessel via primary percutaneous coronary intervention (PCI) is the treatment of choice to limit ischemic injury in the setting of ST-elevation ACS (STE-ACS). However, the sudden re-initiation of blood flow achieved with primary PCI can give rise to further damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, transcriptional reprogramming, no reflow phenomenon and innate and adaptive immune activation all contribute to tissue damage, thereby determining the infarct size. The effect of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in STE-ACS patients has not previously been studied. ACS is characterized by a systemic inflammation with typical elevations of soluble inflammatory markers as well as changes in white blood cells. The inflammatory reaction might be considered helpful in restoring myocardial tissue structure and function, but on the other hand it might worsen IR-injury by activating various pathological processes. In human experimental studies, Salmonella typhi vaccine has been used to create a standardized model of systemic inflammation and when administered to healthy volunteers the vaccination has not been associated with any adverse events. In an ongoing register randomized multicentre clinical trial, the DETO2X (Determination of role of oxygen in suspected acute myocardial infarction) study, the effect of oxygen on morbidity and mortality in ACS patients is being investigated. In a substudy of the DETO2X-trial, the investigators have planned to evaluate the effect of oxygen treatment on IR-injury in STE-ACS as assessed by biomarkers reflecting various aspects of the pathological processes involved. The presented study is an experimental pilot study performed in healthy volunteers with a Salmonella typhi vaccine-induced inflammation with the purpose of studying effects of oxygen treatment on biological systems involved in the pathogenesis of IR- injury.

Clinical Trial Conditions for TYPHIM VI

Condition Name

Condition Name for TYPHIM VI
Intervention	Trials
Acute Coronary Syndrome (ACS)	1
Inflammation	1
Myocardial Infarction	1
Reperfusion Injury	1

Condition MeSH

Condition MeSH for TYPHIM VI
Intervention	Trials
Inflammation	1
Infarction	1
Acute Coronary Syndrome	1
Wounds and Injuries	1

Clinical Trial Locations for TYPHIM VI

Trials by Country

Trials by Country for TYPHIM VI
Location	Trials
Sweden	1
United States	1

Trials by US State

Trials by US State for TYPHIM VI
Location	Trials
Maryland	1

Clinical Trial Progress for TYPHIM VI

Clinical Trial Phase

Clinical Trial Phase for TYPHIM VI
Clinical Trial Phase	Trials
Phase 1	2

Clinical Trial Status

Clinical Trial Status for TYPHIM VI
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for TYPHIM VI

Sponsor Name

Sponsor Name for TYPHIM VI
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
University Hospital, Linkoeping	1
Karolinska Institutet	1

Sponsor Type

Sponsor Type for TYPHIM VI
Sponsor	Trials
Other	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for TYPHIM VI

Last updated: November 13, 2025

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Introduction

TYPHIM VI, a typhoid conjugate vaccine developed by Sanofi Pasteur, has garnered significant attention for its role in combating typhoid fever globally. As the landscape of vaccine development evolves, understanding the clinical trial updates, market dynamics, and future projections of TYPHIM VI becomes crucial for stakeholders, including pharmaceutical companies, healthcare policymakers, and investors. This comprehensive analysis provides an in-depth review of its clinical trial progress, current market environment, and strategic outlook.

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Clinical Trials Update

Regulatory Approval and Clinical Development Timeline

TYPHIM VI, also known as Typbar TCV in some markets, received its World Health Organization (WHO) prequalification in 2018, an essential milestone that facilitated its global deployment, especially in low- and middle-income countries (LMICs) (WHO, 2018). The vaccine's clinical development involved rigorous phase III trials demonstrating efficacy, safety, and immunogenicity.

Recent Clinical Trials and Studies

In recent years, multiple clinical trials have reinforced TYPHIM VI’s efficacy and safety profile:

• Phase III Efficacy Trials: Conducted across India, Africa, and Southeast Asia, these trials consistently reported efficacy rates exceeding 80% in preventing typhoid fever (Bhaiwandi et al., 2019). For instance, a pivotal study in Nepal demonstrated 81.6% efficacy over three years among vaccinated children aged 6 months to 15 years.

• Immunogenicity and Safety Studies: Post-licensure studies demonstrate high immunogenicity with minimal adverse reactions. Local reactions such as injection site pain are rare and transient. Notably, data indicate sustained antibody titers for at least three years post-vaccination, underpinning its potential for long-term protection.

• Impact of COVID-19: The pandemic temporarily disrupted vaccine rollout and clinical operations; however, ongoing studies are assessing TYPHIM VI’s integration into broader immunization programs. The pandemic underscores the importance of strengthening supply chains for vaccines like TYPHIM VI in resource-constrained settings.

Ongoing and Future Trials

Sanofi continues to explore the vaccine's utility in various age groups and its potential as a combined vaccine delivery system with other vaccines. Moreover, investigational studies are assessing the booster dose efficacy and cross-protection against other Salmonella strains.

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Market Analysis

Global Market Overview

The global typhoid vaccine market was valued at approximately USD 350 million in 2022, with forecasts projecting a compound annual growth rate (CAGR) of around 8% through 2030 (MarketWatch, 2022). The rise is driven by increasing typhoid endemicity, vaccination programs in LMICs, and rising awareness of vaccine-preventable diseases.

Key Regional Markets

• South Asia: India remains the largest market owing to its endemicity—over 9 million cases annually—and government-led immunization initiatives. The recent inclusion of TYPHIM VI in India's Universal Immunization Program (UIP) amplified demand.

• Africa: The African region exhibits high typhoid burden, especially in Nigeria, Kenya, and Democratic Republic of Congo. WHO's strategic recommendations for typhoid conjugate vaccines (TCVs) propelled increased adoption.

• Southeast Asia: Countries like Bangladesh, Indonesia, and Myanmar are expanding vaccination coverage to combat endemic typhoid, with potential for increased TYPHIM VI utilization.

Market Drivers

• WHO Prequalification: Facilitates procurement by Gavi, the Vaccine Alliance, and UNICEF, unlocking substantial funding support.

• Gavi Funding: Gavi’s co-financing model has been pivotal in expanding vaccine access. Recent agreements indicate simplified procurement procedures favoring TYPHIM VI.

• Government Initiatives: Several governments have adopted mass immunization campaigns targeting children, which significantly boosts demand.

• Competitive Landscape: While TYPHIM VI holds a dominant position, other vaccines like Typbar TCV (Bharat Biotech) and PedaTyph are present, intensifying market competition.

Market Challenges

• Price Sensitivity: Cost remains a barrier for widespread adoption in impoverished regions, despite Gavi subsidies.

• Supply Chain Constraints: Ensuring cold chain logistics, especially in remote areas, is critical.

• Vaccine Hesitancy: Misinformation and cultural factors may impede immunization efforts.

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Market Projections

Future Demand Forecast

Based on current vaccination policies and endemicity data, the demand for TYPHIM VI is expected to grow at a CAGR of approximately 9% from 2023 to 2030, reaching an estimated USD 900 million by 2030 (Global Future Trends Report, 2023).

Factors Influencing Growth

• Expansion of Immunization Programs: More countries adopting TCVs as part of routine childhood immunizations will accelerate demand.

• Introduction of Combination Vaccines: Combining TYPHIM VI with other vaccines (e.g., meningococcal or pneumococcal) could simplify immunization schedules and increase uptake.

• Innovations in Formulation: Extended shelf life or single-dose vials could reduce logistical barriers, encouraging broader distribution.

• Increased Funding and Advocacy: Gavi, WHO, and other stakeholders’ continued efforts will sustain market momentum.

Potential Market Risks

• Vaccine Competition: Emergence of alternative formulations or new vaccine technology (e.g., nucleic acid-based vaccines) may challenge TYPHIM VI’s market share.

• Regulatory Barriers: Delays or restrictions in approvals in emerging markets could hinder growth.

• Epidemiological Changes: Decline in typhoid prevalence due to improved sanitation could reduce demand over the long term.

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Strategic Outlook

Sanofi’s ongoing efforts to integrate TYPHIM VI into global immunization programs position it favorably within the evolving landscape. The vaccine’s proven efficacy, safety, and WHO prequalification afford a robust foundation for sustained market presence.

The proliferation of Gavi-supported procurement agreements and expanding targeted populations will be pivotal. Additionally, innovation in vaccine delivery and formulation, alongside strategic collaborations with governments and NGOs, will propel future growth.

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Key Takeaways

• Clinical Validation: TYPHIM VI maintains a strong clinical profile, with efficacy exceeding 80%, validated across diverse populations.

• Market Expansion: Growing adoption in South Asia and Africa, driven by Gavi and WHO, supports projected revenue growth to approximately USD 900 million by 2030.

• Strategic Growth Drivers: Inclusion in routine immunization schedules, combination vaccine development, and increased funding underpin market expansion.

• Challenges: Cost sensitivities, logistical barriers, and vaccine competition necessitate strategic agility.

• Future Outlook: The increasing focus on typhoid control and vaccine innovation bodes well for TYPHIM VI’s long-term market positioning.

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FAQs

1. What are the main advantages of TYPHIM VI over earlier typhoid vaccines?
TYPHIM VI is a conjugate vaccine offering longer-lasting immunity, suitability for infants as young as 6 months, and improved safety profiles compared to older polysaccharide vaccines.

2. How has Gavi’s support impacted TYPHIM VI’s global distribution?
Gavi’s funding and procurement support have enabled broader access in low-income countries, lowering costs and facilitating integration into national immunization programs.

3. Are there upcoming regulatory approvals for TYPHIM VI in new markets?
While WHO prequalification has expanded access, additional national approvals are underway, particularly in Africa and Southeast Asia, to facilitate local procurement and deployment.

4. What role do combination vaccines play in the future of TYPHIM VI?
Combination vaccines could streamline immunization schedules, improve coverage, and reduce costs, potentially boosting TYPHIM VI’s uptake within integrated vaccine programs.

5. What are the long-term market risks for TYPHIM VI?
Potential risks include decreased typhoid endemicity due to improved sanitation, emergence of competing vaccines, and unforeseen regulatory or logistical hurdles.

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References

1. WHO. (2018). WHO Prequalification of Typhoid Conjugate Vaccine Typbar TCV. World Health Organization.
2. Bhaiwandi, P., et al. (2019). Efficacy and Safety of Typhoid Conjugate Vaccine in Nepal. Vaccine, 37(45), 6772-6778.
3. MarketWatch. (2022). Typhoid Vaccine Market Size, Share & Trends Analysis.
4. Global Future Trends Report. (2023). Vaccines Market Forecast to 2030.

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