*First in Human SPYVLP01 vaccine study in healthy adult volunteers
Research type
Research Study
Full title
A Phase I First in Human Study to Assess Safety and Immunogenicity of the Human Cytomegalovirus Vaccine Candidate SPYVLP01 With and Without Adjuvants in Healthy Adult Volunteers
IRAS ID
1008565
Contact name
Gemma Jones
Contact email
Sponsor organisation
SpyBiotech Limited
Clinicaltrials.gov Identifier
Research summary
The Sponsor, SpyBiotech Limited, is developing a new experimental vaccine SPYVLP01 for pregnant women and women who are able to/want to become pregnant for the purpose of preventing transmission of a common virus called Human Cytomegalovirus (HCMV) to developing babies.
HCMV is a common virus that most people are exposed to at some point in their lifetime without their knowledge. It can infect people of all ages regardless of their cultural background. Over 50% of adults in the UK are infected with HCMV. When a baby is born with CMV they can develop health problems, for example, hearing loss, seizures and developmental delay. Around 1 in 1,000 babies born in the UK every year will have permanent disabilities such as hearing loss as a result of CMV. This is around 2 to 3 babies born every day in the UK.
If a HCMV vaccine can be given to pregnant women or women prior to becoming pregnant it could prevent transmission to the developing baby whilst the mother is carrying the baby in her uterus and help reduce long term disabilities in newborn babies.
The purpose of this research study is to determine whether the vaccine, SPYVLP01, is safe and what common vaccine related reactions (e.g. sore arm, temperature, redness around the injection site) occur in healthy participants.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0249
Date of REC Opinion
3 Nov 2023
REC opinion
Further Information Favourable Opinion