Last reviewed 2026-05-25 · How we verify

HPV9v

Fundacion SEIMC-GESIDA · FDA-approved active Biologic Under review

HPV9v is a Recombinant vaccine Biologic drug developed by Fundacion SEIMC-GESIDA. It is currently FDA-approved for Prevention of cervical cancer and precancerous lesions caused by HPV types 16, 18, 31, 33, 45, 52, and 58, Prevention of genital warts caused by HPV types 6 and 11, Prevention of other HPV-related anogenital and oropharyngeal cancers. Also known as: Gardasil9.

HPV9v is a 9-valent human papillomavirus vaccine that stimulates immune responses against nine HPV types to prevent infection and HPV-related cancers.

HPV9v is a nonavalent vaccine against human papillomavirus. It is being studied in a clinical trial (NCT03626467) to evaluate its immunogenicity in men infected with HIV who have sex with men.

At a glance

Generic name	HPV9v
Also known as	Gardasil9
Sponsor	Fundacion SEIMC-GESIDA
Drug class	Recombinant vaccine
Target	Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58
Modality	Biologic
Therapeutic area	Oncology / Immunology / Infectious Disease
Phase	FDA-approved

Mechanism of action

The vaccine contains virus-like particles (VLPs) derived from nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58) that trigger both humoral and cellular immune responses. This immunization prevents infection by these HPV strains, thereby reducing the risk of cervical cancer, other anogenital cancers, and oropharyngeal cancers in vaccinated individuals.

Approved indications

Prevention of cervical cancer and precancerous lesions caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Prevention of genital warts caused by HPV types 6 and 11
Prevention of other HPV-related anogenital and oropharyngeal cancers

Common side effects

Injection site pain
Injection site swelling
Injection site erythema
Fever
Myalgia
Headache

Key clinical trials

A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017 (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

HPV9v CI brief — competitive landscape report
HPV9v updates RSS · CI watch RSS
Fundacion SEIMC-GESIDA portfolio CI

Frequently asked questions about HPV9v

What is HPV9v?

HPV9v is a Recombinant vaccine drug developed by Fundacion SEIMC-GESIDA, indicated for Prevention of cervical cancer and precancerous lesions caused by HPV types 16, 18, 31, 33, 45, 52, and 58, Prevention of genital warts caused by HPV types 6 and 11, Prevention of other HPV-related anogenital and oropharyngeal cancers.

How does HPV9v work?

HPV9v is a 9-valent human papillomavirus vaccine that stimulates immune responses against nine HPV types to prevent infection and HPV-related cancers.

What is HPV9v used for?

HPV9v is indicated for Prevention of cervical cancer and precancerous lesions caused by HPV types 16, 18, 31, 33, 45, 52, and 58, Prevention of genital warts caused by HPV types 6 and 11, Prevention of other HPV-related anogenital and oropharyngeal cancers.

Who makes HPV9v?

HPV9v is developed and marketed by Fundacion SEIMC-GESIDA (see full Fundacion SEIMC-GESIDA pipeline at /company/fundacion-seimc-gesida).

Is HPV9v also known as anything else?

HPV9v is also known as Gardasil9.

What drug class is HPV9v in?

HPV9v belongs to the Recombinant vaccine class. See all Recombinant vaccine drugs at /class/recombinant-vaccine.

What development phase is HPV9v in?

HPV9v is FDA-approved (marketed).

What are the side effects of HPV9v?

Common side effects of HPV9v include Injection site pain, Injection site swelling, Injection site erythema, Fever, Myalgia, Headache.

What does HPV9v target?

HPV9v targets Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58 and is a Recombinant vaccine.

Drug class: All Recombinant vaccine drugs
Target: All drugs targeting Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58
Manufacturer: Fundacion SEIMC-GESIDA — full pipeline
Therapeutic area: All drugs in Oncology / Immunology / Infectious Disease
Indication: Drugs for Prevention of cervical cancer and precancerous lesions caused by HPV types 16, 18, 31, 33, 45, 52, and 58
Indication: Drugs for Prevention of genital warts caused by HPV types 6 and 11
Indication: Drugs for Prevention of other HPV-related anogenital and oropharyngeal cancers
Also known as: Gardasil9

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing