Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A phase 1 Clinical Trial to Evaluate Safety and Immunogenecity of HIV SOSIP v8.2 763 Vaccine in healthy individuals

This early-stage study is looking at a new vaccine called HIV SOSIP v8.2 763. It's designed to help protect people from HIV, the virus that can cause AIDS. This is the first time the vaccine is being given to humans, so the main goal is to check if it's safe and if it encourages the body's immune system to make a response against HIV. Researchers also want to find the right amount of vaccine to give. This important first step helps us learn more about potential new ways to prevent HIV infection in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Consorcio Centro De Investigacion Biomedica En Red

Enrolment target

Start

16 Jan 2025

Human Immunodeficiency Virus (HIV)

What is this study about?

This research study is about finding a new way to prevent HIV, which is the virus that causes AIDS. Scientists are developing a new vaccine, and this particular study is one of the very first times they are giving it to people to see how it works. Think of it like a new medicine or protective treatment being tested for the first time.

The main goals of this study are to make sure the vaccine is safe for people and to see if it helps your body's defence system (your immune system) learn to fight off the HIV virus. If your immune system can recognise and fight the virus, it could help protect you from getting HIV in the future. Finding a safe and effective vaccine is a big step towards preventing HIV globally.

Because this is such an early study, researchers are also trying to figure out the best amount, or 'dose', of the vaccine to give. This helps them plan future, larger studies to confirm if the vaccine truly works and for how long. Every step in this process is carefully planned to ensure safety and gather as much information as possible.

Key takeaways

This study is testing a new possible HIV vaccine for the first time in people.
The main goals are to check the vaccine's safety and if it helps your body create a protective response.
It's a very early-stage study, so it's not known yet if the vaccine will work to prevent HIV.
Participants must be healthy adults (18 years or older).
Taking part involves multiple clinic visits for vaccine doses and health check-ups.
You can withdraw from the study at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There isn't an upper age limit mentioned, so older adults could also be considered.

Both men and women can take part in this research. The study needs healthy volunteers to make sure any effects seen are from the vaccine and not from other health conditions you might have.

Because you need to be healthy, the research team will do some checks to make sure you're suitable. They'll ask about your medical history and do some tests to confirm you're in good health before you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend several clinic appointments?
Are you willing to learn more about a new HIV vaccine research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new vaccine. This study will involve several visits to a clinic over a period of time. During these visits, the research team will monitor your health carefully. This includes regular check-ups, blood tests, and possibly other assessments to see how your body is reacting to the vaccine. They will also be looking for any side effects and how well your immune system is responding. The total duration of your participation, including all follow-up appointments, will be explained in detail before you agree to join.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of helping medical science develop a new vaccine to protect against HIV, which could benefit many people in the future. However, there are also potential risks, as this is a new vaccine never given to humans before. You might experience side effects, which could range from mild, like a sore arm or feeling tired, to more serious reactions. All risks will be fully explained, and you have the right to withdraw from the study at any time without giving a reason, which will not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is HIV?

HIV (Human Immunodeficiency Virus) is a virus that attacks the body's immune system, which is its natural defence against illness. If untreated, it can lead to AIDS.

What does 'vaccine' mean?

A vaccine is a substance given to train your body's immune system to recognise and fight off a specific disease, helping to protect you from getting sick.

What does "Phase 1" mean for a study?

Phase 1 means this is one of the very first times the vaccine is being tested in people. The main goals are to check if it's safe and to learn how the body reacts to it.

Will taking part expose me to HIV?

No, this vaccine is designed to teach your body to fight HIV, not to infect you with the virus. The vaccine does not contain the live HIV virus.

Do I have to pay to join this study?

No, you do not have to pay to participate in a clinical trial. All study-related care and the vaccine itself are provided at no cost.