CLINICAL TRIALS PROFILE FOR VIVOTIF

All Clinical Trials for VIVOTIF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01019083 ↗	Studies of Immune Responses to Orally Administered Vaccines in Developing Country	Completed	Göteborg University	Phase 1/Phase 2	2008-02-01	The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT01019083 ↗	Studies of Immune Responses to Orally Administered Vaccines in Developing Country	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 1/Phase 2	2008-02-01	The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.
NCT03705585 ↗	CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera	Recruiting	University of Maryland	Phase 4	2018-11-05	This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.
NCT03705585 ↗	CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera	Recruiting	University of Maryland, Baltimore	Phase 4	2018-11-05	This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups: Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination. Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.
NCT03970304 ↗	CVD 37000: Immunity and Microbiome Studies at Intestinal and Systemic Sites in Ty21a Vaccinated Adults	Active, not recruiting	University of Maryland	Phase 4	2013-10-24	This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever affect the normal immune system and bacteria in the intestine. Patients having standard-of-care colonoscopies will be divided into 3 groups: Group 1: Vivotif typhoid vaccination then colonoscopy; Group 2: Colonoscopy, then Vivotif typhoid vaccination, then follow-up colonoscopy; Group 3: Colonoscopy without vaccination. The Vivotif typhoid vaccine used in this study is licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid vaccine.

Clinical Trial Conditions for VIVOTIF

Condition Name

Condition Name for VIVOTIF
Intervention	Trials
Typhoid Vaccination	1
Cholera	1
Risk Reduction	1
Typhoid	1

Condition MeSH

Condition MeSH for VIVOTIF
Intervention	Trials
Typhoid Fever	3
Cholera	2

Clinical Trial Locations for VIVOTIF

Trials by Country

Trials by Country for VIVOTIF
Location	Trials
United States	3
Bangladesh	1

Trials by US State

Trials by US State for VIVOTIF
Location	Trials
Maryland	3

Clinical Trial Progress for VIVOTIF

Clinical Trial Phase

Clinical Trial Phase for VIVOTIF
Clinical Trial Phase	Trials
Phase 4	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for VIVOTIF
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for VIVOTIF

Sponsor Name

Sponsor Name for VIVOTIF
Sponsor	Trials
University of Maryland	3
University of Maryland, Baltimore	3
International Centre for Diarrhoeal Disease Research, Bangladesh	1

Sponsor Type

Sponsor Type for VIVOTIF
Sponsor	Trials
Other	8

VIVOTIF (Typhoid Vaccine Live Oral Ty21a): Clinical Trials Update, Market Analysis, and Supply-Based Projections

Last updated: May 8, 2026

What is VIVOTIF and what does the current clinical evidence indicate?

VIVOTIF is a live, oral typhoid vaccine (Ty21a). In practice, its clinical value is tied to field efficacy against typhoid fever and immunogenicity durability across endemic settings, plus therapeutic and safety performance consistent with a live oral product.

Evidence base used for commercial adoption

Commercial use of VIVOTIF historically rests on:

• Immunogenicity readouts (e.g., antigen-specific responses such as anti-S. Typhi LPS/whole-cell responses) after the recommended oral dosing schedule.
• Clinical efficacy demonstrated in endemic settings, where attack rates and circulating S. Typhi serotypes materially influence observed endpoints.
• Safety/tolerability consistent with live oral vaccine administration (mostly gastrointestinal events and transient systemic symptoms in a subset of recipients).

Key constraint for “trial updates”: VIVOTIF is an older marketed product, and new sponsor-driven Phase 3 efficacy trials are not the primary driver of ongoing evidence; instead, regulators and markets typically rely on bridging, label maintenance, stability/manufacturing continuity, and (where available) newer immunogenicity comparisons.

Which trial updates matter for decision-making now?

Across vaccine markets, what changes the investment or commercial outlook for an established typhoid vaccine is rarely a single headline efficacy Phase 3. It is typically one or more of:

1. Formulation, manufacturing, and lot consistency approvals (including stability and process changes).
2. Age-group expansion or guideline alignment with local immunization schedules.
3. Immunogenicity bridging used to support label maintenance when formulation or process is modified.
4. Competitive sequencing against newer typhoid products that may shift preference in procurement tenders.

For VIVOTIF, there is no indication in the available public record used here that a brand-new, large Phase 3 efficacy program is the dominant ongoing development signal. The practical “update” for commercial stakeholders is therefore tied to deployment conditions and procurement rather than to a fresh clinical efficacy milestone.

How does VIVOTIF compete in the typhoid vaccine market?

Competitive landscape and switching dynamics

The typhoid vaccine market has two structural dynamics that affect VIVOTIF demand:

• Shift toward parenteral typhoid conjugate vaccines (TCVs) in many procurement strategies because TCVs generally have higher effectiveness and longer protection for targeted endemic cohorts compared with older typhoid vaccine approaches.
• Role retention for oral typhoid vaccines where they provide value via ease of administration, logistics, and acceptability in campaigns or risk-based programs.

Implication for VIVOTIF: Market share is commonly constrained by TCV uptake. VIVOTIF tends to hold or grow in segments where oral administration is operationally favorable, or where budget and procurement windows favor existing oral products.

What is the market size and growth outlook for typhoid vaccines relevant to VIVOTIF?

Market drivers

Demand is driven by:

• Ongoing endemic burden of S. Typhi in parts of Asia and Africa.
• Mass vaccination and outbreak prevention efforts.
• National immunization program planning and support from global health procurement mechanisms.
• Household and traveler needs in non-endemic and intermittently endemic routes (where travelers’ vaccination programs maintain baseline demand).

The projection logic for an established product

For VIVOTIF specifically, a credible projection requires translating market drivers into a share-and-supply model:

• Total typhoid vaccine demand (campaign + routine + traveler segments).
• Segment mix shift from older products to TCVs.
• Oral vaccine share relative to parenteral products.
• Procurement cycles (tender timing, batch scheduling).
• Supply continuity (ability to meet orders without stock-outs).

Since VIVOTIF’s growth is typically share-limited rather than biologically innovation-limited, scenario outcomes are primarily driven by:

• Whether oral typhoid vaccine procurement remains open in priority countries, and
• Whether TCV rollouts displace oral vaccines faster than new oral contracts offset.

What do procurement and geography imply for VIVOTIF volume?

Likely demand geographies (procurement and traveler channels)

VIVOTIF’s market footprint is generally associated with:

• Endemic-country procurement where typhoid immunization is supported for children and at-risk populations.
• Traveler demand in higher-income markets, where travelers’ typhoid risk guidance sustains a recurring baseline.

Oral product execution advantage

Oral dosing can lower execution friction in some campaign environments:

• No needle requirement.
• Potentially lower administration cost per vaccinated individual.
• Logistics compatible with routine program workflows in settings that already distribute oral products.

What is the 5-year market projection for VIVOTIF?

Projection framework

The projection below is built on a practical business model rather than on optimistic clinical assumptions:

• Base demand = endemic typhoid vaccine consumption where oral products are still procured plus traveler dosing.
• Share trend = gradual reduction of oral share as TCVs expand.
• Volume sensitivity = procurement timing and supply continuity.

5-year outlook (directional)

Because public clinical and label-update signals for VIVOTIF do not indicate a major efficacy novelty or expansion that would rapidly reverse a TCV displacement trend, the most decision-relevant forecast for VIVOTIF is:

• Moderate, uneven volume with pressure from TCV substitution,
• Possible temporary step-ups in contracts due to campaign planning cycles,
• Limited upside unless oral procurement remains protected or specific program requirements favor oral Ty21a.

Numeric projections are not provided here because the prompt requires “hard data,” and the necessary public inputs (current market size by segment, VIVOTIF unit sales, tender award data, and supply constraints by manufacturer) are not provided in the source material available for citation in this response.

What are the key supply, regulatory, and commercialization constraints affecting projections?

Supply and manufacturing continuity

For established live oral vaccines, commercial performance is influenced by:

• Batch availability and fill-finish scheduling.
• Stability and cold-chain or temperature requirements in distribution networks (as defined in product handling instructions).
• Regulatory release timing and import approvals in target countries.

Tender competitiveness

VIVOTIF competes in procurement contexts where decision criteria can include:

• Price per dose.
• Programmatic fit (oral administration workflow).
• Evidence accepted by procurement agencies.
• Inclusion in national or donor-funded typhoid vaccine strategies.

Risk factors to plan around

• Faster TCV adoption than expected in endemic programs.
• Procurement shifts due to donor guidance or national policy refresh.
• Counterparty preference for conjugate options in catch-up campaigns.

What should an investor or R&D leader do with this clinical and market read?

Clinical take

• Treat VIVOTIF as a mature, field-proven product where value is maintained by consistent performance and logistics, not by new efficacy breakthroughs.

Market take

• Assume continued pressure from TCVs but plan for survivable demand through oral-specific program needs, traveler demand, and selective procurement.

Commercial take

• Prioritize channel and tender strategy aligned to countries and buyer segments that still use oral typhoid vaccines, rather than expecting a rapid share rebound absent policy shifts.

Key Takeaways

• VIVOTIF is an established oral Ty21a typhoid vaccine with ongoing relevance driven by field use, logistics, and procurement cycles rather than new large Phase 3 efficacy readouts.
• TCV expansion is the structural headwind; VIVOTIF market outcomes are primarily share- and procurement-cycle driven.
• Projections for VIVOTIF should be supply- and tender-aware and modeled as moderate, uneven volume with TCV displacement pressure.

FAQs

1. Is VIVOTIF still active in development pipelines?
   For business planning, VIVOTIF is treated as a mature marketed product where the most meaningful “updates” are label maintenance and program fit rather than new pivotal efficacy trials.

2. Why does oral typhoid vaccine demand persist despite TCV growth?
   Oral administration can reduce delivery friction in some campaign settings, and procurement can still favor Ty21a in specific program and cost contexts.

3. What is the main market risk for VIVOTIF?
   Faster replacement of oral typhoid vaccines by TCVs in endemic-country and donor-supported strategies.

4. What drives near-term sales changes most for established vaccines?
   Tender timing, procurement awards, importer batch releases, and distribution continuity.

5. How should VIVOTIF be modeled in a forecasting spreadsheet?
   Use a share-of-typhoid-vaccine-demand approach with explicit substitution pressure from TCVs and incorporate procurement-cycle seasonality.

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References

[1] World Health Organization. Typhoid vaccines: WHO position paper. WHO.
[2] CDC. Typhoid and paratyphoid fever: Vaccine recommendations. Centers for Disease Control and Prevention.
[3] VIVOTIF (typhoid vaccine live oral Ty21a) prescribing information / product labeling (official package insert).