V118C Safety Study in Healthy Adults

Recruiting at 2 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Pneumococcal disease, Endocrine, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for V118C in humans?

The safety of V118C in humans has not been specifically addressed in the provided research articles. However, these studies highlight that adverse events in phase I trials are common and often unrelated to the drug being tested, emphasizing the importance of careful monitoring and ethical oversight in such trials. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This clinical trial is for healthy adults who are in good health before being randomly assigned to a treatment group. Specific eligibility details aren't provided, but typically participants should not have any significant underlying health conditions.

Inclusion Criteria

Is in good health before randomization

Exclusion Criteria

I had a serious lung infection or other pneumococcal disease in the last 3 years.

I have a significant history of major health issues like heart, liver, or kidney diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections in a 2-dose regimen on Day 1 and Day 29

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• V118C

Trial Overview The study is testing the safety and tolerability of V118 Formulation C (V118C) compared to PREVNAR 20™ and saline. Participants will be given one of these treatments to see how their bodies react.

Participant Groups

Group I: V118C Experimental Treatment 1 Intervention

Participants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.

Group II: V118 Experimental Treatment 2 Interventions

Participants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.

Group III: PREVNAR 20™ + Saline Active Control 2 Interventions

Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Pre-clinical studies in animals cannot be directly applied to humans, highlighting the necessity for thorough pre-therapeutical studies to understand how new drugs are absorbed, distributed, metabolized, and excreted (ADME) in humans.

Safety is the top priority in human clinical trials, which must follow approved protocols and be monitored closely, yet there are legal and ethical challenges in conducting studies with healthy volunteers in France, necessitating clearer legislation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current practice of drug trials in healthy volunteers]. Duchier, J.[2007]

In a review of 231 randomized placebo-controlled clinical trials, it was found that a staggering 96.8% of adverse events (AEs) reported in patients taking active drugs were nonspecific, meaning they were not directly related to the medication.

The study revealed strong correlations between AE rates in placebo and active-drug groups, indicating that many reported AEs may not be caused by the drug itself, which raises concerns about the reliability of clinical trial data in assessing drug tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. Mahr, A., Golmard, C., Pham, E., et al.[2022]

In a study comparing 192 healthy volunteers in Phase I drug trials to a control group of 112 matched individuals, the Phase I participants reported significantly fewer common complaints like headaches, stomach pain, and anxiety, suggesting they may have a lower tendency to report non-drug-related adverse events.

Psychological factors, such as anxiety and depression, were found to correlate positively with the incidence of complaints, while higher self-efficacy was associated with fewer complaints, indicating that psychological characteristics can influence the reporting of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. Almeida, L., Coelho, R., Albino-Teixeira, A., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

3. France pubmed.ncbi.nlm.nih.gov

[Current practice of drug trials in healthy volunteers]. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. [2019]