Human papillomavirus type 16 L1 capsid protein antigen

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Name
Human papillomavirus type 16 L1 capsid protein antigen
Accession Number
DB10301
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Other vaccines
Description

Human papillomavirus type 16 L1 capsid protein antigen is contained in Gardasil, or a recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) vaccine for intramuscular injection. It is an immunization for young men and women 9-26 years of age for the prevention of diseases caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18, which are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs.

Synonyms
  • L1 protein, Human papillomavirus type 16 Vaccine
  • Recombinant human papillomavirus type 16 L1 protein
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
CervarixHuman papillomavirus type 16 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 18 L1 capsid protein antigen (20 mcg)SuspensionIntramuscularGlaxosmithkline Inc2010-02-10Not applicableCanada
GardasilHuman papillomavirus type 16 L1 capsid protein antigen (40 mcg) + Human papillomavirus type 11 L1 capsid protein antigen (40 mcg) + Human papillomavirus type 18 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 6 L1 capsid protein antigen (20 mcg)SuspensionIntramuscularMerck Ltd.2006-08-162019-08-22Canada
GardasilHuman papillomavirus type 16 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (20 ug/0.5mL)Injection, suspensionIntramuscularA-S Medication Solutions2006-06-08Not applicableUs
GardasilHuman papillomavirus type 16 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (20 ug/0.5mL)Injection, suspensionIntramuscularMerck Sharp & Dohme Corp.2006-06-08Not applicableUs
GardasilHuman papillomavirus type 16 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (20 ug/0.5mL)Injection, suspensionIntramuscularMerck Sharp & Dohme Corp.2006-06-08Not applicableUs
GardasilHuman papillomavirus type 16 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (20 ug/0.5mL)Injection, suspensionIntramuscularRemedy Repack2014-02-132015-02-11Us
Gardasil 9Human papillomavirus type 16 L1 capsid protein antigen (60 mcg) + Human papillomavirus type 11 L1 capsid protein antigen (40 mcg) + Human papillomavirus type 18 L1 capsid protein antigen (40 mcg) + Human papillomavirus type 31 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 33 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 45 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 52 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 58 L1 capsid protein antigen (20 mcg) + Human papillomavirus type 6 L1 capsid protein antigen (30 mcg)SuspensionIntramuscularMerck Ltd.2015-03-18Not applicableCanada
Gardasil 9Human papillomavirus type 16 L1 capsid protein antigen (60 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 31 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 33 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 45 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 52 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 58 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (30 ug/0.5mL)Injection, suspensionIntramuscularMerck Sharp & Dohme Corp.2014-12-10Not applicableUs
Gardasil 9Human papillomavirus type 16 L1 capsid protein antigen (60 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 31 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 33 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 45 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 52 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 58 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (30 ug/0.5mL)Injection, suspensionIntramuscularMerck Sharp & Dohme Corp.2014-12-10Not applicableUs
Gardasil 9Human papillomavirus type 16 L1 capsid protein antigen (60 ug/0.5mL) + Human papillomavirus type 11 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 18 L1 capsid protein antigen (40 ug/0.5mL) + Human papillomavirus type 31 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 33 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 45 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 52 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 58 L1 capsid protein antigen (20 ug/0.5mL) + Human papillomavirus type 6 L1 capsid protein antigen (30 ug/0.5mL)Injection, suspensionIntramuscularA-S Medication Solutions2014-12-10Not applicableUs
Categories
UNII
6LTE2DNX63
CAS number
Not Available

Pharmacology

Indication
Not Available
Associated Conditions
Pharmacodynamics
Not Available
Mechanism of action
Not Available
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
Not Available
External Links
PubChem Substance
347910487
RxNav
798264

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0WithdrawnTreatmentRecurrent Respiratory Papillomatosis1
1CompletedPreventionCervical Cancers / Cervical Dysplasia / Cervical Intraepithelial Neoplasia (CIN) / Cervical Neoplasms / Human Papillomavirus (HPV)1
1CompletedPreventionCervical Cancers / Human Papilloma Virus (HPV) / Vaginal Cancers / Vulvar Cancers / Wart, Genital1
1CompletedPreventionCervical Cancers / Nonneoplastic Condition / Precancerous Conditions1
1CompletedPreventionCervical Neoplasia / Human Papillomavirus (HPV) Infection / Papillomavirus Infections1
1CompletedPreventionHuman Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
1CompletedPreventionPapillomavirus Infections1
1CompletedTreatmentGardasil Vaccine / Hematopoietic Stem Cell Transplant (HSCT) / Immunogenicity1
1Not Yet RecruitingPreventionAnal Intraepithelial Neoplasia (AIN) / Cancer, Anal / Human Papilloma Virus (HPV)1
1Not Yet RecruitingTreatmentHuman Immunodeficiency Virus (HIV) Infections1
1Unknown StatusPreventionSystemic Lupus Erythematosus (SLE)1
1, 2CompletedPreventionViral Hepatitis B1
1, 2RecruitingPreventionHuman Papilloma Virus Vaccine1
2Active Not RecruitingNot AvailableSystemic Immune Disease / Systemic Lupus Erythematosus (SLE) / Transplantations1
2Active Not RecruitingPreventionCancer Survivors / Prevention of Human Papillomavirus Infection1
2Active Not RecruitingPreventionHealthy Volunteers / Human Papillomavirus Infections / No Evidence of Disease1
2Active Not RecruitingPreventionHuman Papillomavirus (HPV)1
2CompletedPreventionCervical Cancers / Hpv / Premalignancy Anogenital Warts1
2CompletedPreventionCervical Neoplasia / HPV-16/18 Infections / Papillomavirus Infections1
2CompletedPreventionCervical Neoplasia / Human Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
2CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Sexually Transmitted Disease (STD)1
2CompletedPreventionHuman Papillomavirus (HPV)2
2CompletedPreventionHuman Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
2CompletedPreventionMeningitis / Meningococcal Infections / Meningococcal Meningitis1
2CompletedPreventionMeningococcal Vaccines / Vaccines1
2CompletedPreventionPapillomavirus Infections2
2CompletedPreventionPapillomavirus Infections / Prophylaxis HPV Infection1
2CompletedTreatmentInfection / Precancerous Conditions1
2RecruitingPreventionHPV-Related Cervical Carcinoma / Human Papillomavirus (HPV)1
2RecruitingPreventionIdiopathic CD4 T Cell Lymphocytopenia1
2RecruitingTreatmentCervical Cancers / Cervical Neoplasms / Cervix Cancer / Uterine Cervical Neoplasms1
2SuspendedPreventionTransplantation, Kidney1
2, 3CompletedNot AvailableCervical Cancers / External Genital Warts1
3Active Not RecruitingPreventionAIDS-Related Human Papillomavirus Infection / High Grade Cervical Squamous Intraepithelial Neoplasia / Human Immunodeficiency Virus (HIV) Infections1
3Active Not RecruitingPreventionAnti-HPV Antibody Levels / Cervical Cancers1
3Active Not RecruitingPreventionCervical Cancers / Wart, Genital1
3Active Not RecruitingPreventionHuman Papilloma Virus (HPV)1
3Active Not RecruitingPreventionHuman Papillomavirus Infections1
3Active Not RecruitingPreventionPapillomavirus Infections1
3Active Not RecruitingPreventionPrevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ1
3CompletedPreventionAdenocarcinoma in Situ / Condylomata Acuminata / Papillomavirus Infections / Uterine Cervical Neoplasms / Vaginal Neoplasms / Vulvar Neoplasms1
3CompletedPreventionAnogenital Human Papilloma Virus Infection / Condylomata Acuminata2
3CompletedPreventionAssociated Cervical Neoplasia / Human Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines2
3CompletedPreventionCervical Cancers1
3CompletedPreventionCervical Cancers / Human Papillomavirus Infections / Vaginal Cancers / Vulvar Cancers / Wart, Genital2
3CompletedPreventionCervical Cancers / Papillomavirus Infection / Papillomavirus Infections1
3CompletedPreventionCervical Cancers / Precancerous Conditions1
3CompletedPreventionCervical Cancers / Wart, Genital4
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Human Papillomavirus Infections / Papillomavirus Infections / Papillomavirus Vaccines1
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Human Papillomavirus Infections / Papillomavirus Infections / Papillomavirus Vaccines / Viral Hepatitis B1
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Papillomavirus Infection1
3CompletedPreventionCervical Intraepithelial Neoplasia (CIN) / Papillomavirus Type 16/18 Infection1
3CompletedPreventionCervical Neoplasia / HPV-16/18 Infections / Human Papillomavirus (HPV) Infection / Papillomavirus Infections1
3CompletedPreventionCervical Neoplasia / Human Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines2
3CompletedPreventionCondylomata Acuminata1
3CompletedPreventionDengue Fever / Dengue Hemorrhagic Fever / Human Papillomavirus Disease2
3CompletedPreventionDiphtheria / Meningitis / Neoplasms, Glandular and Epithelial / Tetanus / Whooping Cough1
3CompletedPreventionHPV Vaccines Immunogenicity and Safety1
3CompletedPreventionHPV-16/18 Infections and Associated Cervical Neoplasia / Papillomavirus Infections / Papillomavirus Vaccines1
3CompletedPreventionHPV-16/18 Infections and Cervical Neoplasia / Papillomavirus Infections1
3CompletedPreventionHPV-16/18 Infections / Papillomavirus Infections1
3CompletedPreventionHuman Papillomavirus (HPV)3
3CompletedPreventionHuman Papillomavirus (HPV) Infection / Papillomavirus Infections / Papillomavirus Vaccines1
3CompletedPreventionHuman Papillomavirus (HPV) Type 16/18 Infections and Cervical Neoplasia / Papillomavirus Infections1
3CompletedPreventionHuman Papillomavirus Vaccines1
3CompletedPreventionHumans / Papillomavirus Infections1
3CompletedPreventionMeningococcal Infections1
3CompletedPreventionPapilloma Viral Infection1
3CompletedPreventionPapillomavirus Infections13
3CompletedPreventionPapillomavirus Infections / Papillomavirus Vaccines4
3CompletedPreventionTransplanted1
3Not Yet RecruitingPreventionCervical Intraepithelial Neoplasia (CIN)1
3RecruitingPreventionAIS / Cervical Cancers / CIN1 / CIN2 / CIN3 / Vaginal Cancers / VaIN1 / VaIN2 / VaIN3 / VIN 1 / VIN 2 / VIN 3 / Vulvar Cancers / Wart, Genital2
3RecruitingPreventionHuman Papilloma Virus (HPV)1
3RecruitingPreventionHuman Papillomavirus Vaccines1
3RecruitingPreventionPapillomavirus Infections1
3RecruitingPreventionWart, Genital2
3Unknown StatusPreventionHpv / Human Immunodeficiency Virus (HIV) Infections1
3Unknown StatusTreatmentRecurrent Respiratory Papillomatosis1
3WithdrawnPreventionPapillomavirus Infections1
4Active Not RecruitingPreventionAnti-HPV Antibody Patterns / Cervical Cancers / Cervical HPV Infection / Sexually Transmitted Infections (STIs)1
4Active Not RecruitingPreventionCervical Cancers / Cervical Precancerous Lesions1
4Active Not RecruitingPreventionComplication of Transplanted Liver / Human Papillomavirus-Related Carcinoma / Late Complication From Kidney Transplant1
4Active Not RecruitingPreventionPapillomavirus Infections1
4CompletedOtherHealthy Volunteers1
4CompletedPreventionAIN / Human Immunodeficiency Virus (HIV) Infections1
4CompletedPreventionAdenocarcinoma in Situ / Cervical Cancers / Cervical Intraepithelial Neoplasia (CIN)1
4CompletedPreventionCervical Cancers3
4CompletedPreventionCervical Intraepithelial Neoplasia (CIN)1
4CompletedPreventionHuman Immunodeficiency Virus (HIV) Infections / Human Papillomavirus (HPV)1
4CompletedPreventionHuman Papillomavirus (HPV)1
4CompletedPreventionHuman Papillomavirus Infections1
4CompletedPreventionInflammatory Bowel Diseases (IBD) / Uterine Cervical Dysplasia1
4CompletedPreventionPapillomavirus Infections2
4CompletedPreventionSystemic Lupus Erythematosus (SLE)1
4Not Yet RecruitingBasic ScienceHuman Papillomavirus (HPV)1
4Not Yet RecruitingPreventionHIV Infected Children / HPV Vaccination1
4RecruitingNot AvailableInfection With Human Papillomavirus1
4RecruitingPreventionAllogeneic Hematopoietic Stem Cell Transplant Recipient / Allogeneic Hematopoietic Stem Cell Transplantation Recipient / Hematopoietic and Lymphoid Cell Neoplasm / Human Papillomavirus (HPV)1
4RecruitingPreventionHuman Papillomavirus Infections1
4RecruitingPreventionPapillomavirus Vaccines1
4SuspendedTreatmentHigh Grade Anal Canal Squamous Intraepithelial Neoplasia / Vulvar High Grade Squamous Intraepithelial Lesion1
4TerminatedPreventionHPV-16/18 Infections and Associated Cervical Neoplasia / Human Papillomavirus Infection Leading to Cervical Cancer1
4TerminatedPreventionHuman Papillomavirus Infections1
4Unknown StatusPreventionCervical Cancers / HPV Related Diseases / Human Papillomavirus (HPV) / Precancerous Disease of the Cervix1
4Unknown StatusPreventionCervical Cancers / Hpv / Warts1
Not AvailableActive Not RecruitingNot AvailableCervical Cancers / Human Papillomavirus Infections / Vaginal Cancers / Vulvar Cancers / Wart, Genital1
Not AvailableCompletedNot AvailableChronic Kidney Disease (CKD)1
Not AvailableCompletedNot AvailableEvaluating Attitudes Toward HPV Vaccinations in Pharmacies / Evaluating the Provision of HPV Vaccines in a Pharmacy1
Not AvailableCompletedNot AvailableHealthy Volunteers1
Not AvailableCompletedNot AvailableHuman Immunodeficiency Virus Type 1 (HIV-1) Infection / Human Papillomavirus (HPV)1
Not AvailableCompletedNot AvailablePapillomavirus Infections4
Not AvailableCompletedBasic ScienceSexually Transmitted Diseases, Viral1
Not AvailableCompletedPreventionCervical Cancers1
Not AvailableCompletedPreventionHuman Papillomavirus Infections1
Not AvailableCompletedPreventionHuman Papillomavirus Vaccines / Quadrivalent HPV Vaccine1
Not AvailableCompletedPreventionInflammatory Bowel Diseases (IBD)1
Not AvailableCompletedPreventionSexual Transmission of Infection1
Not AvailableCompletedPreventionSystemic Lupus Erythematosus (SLE)1
Not AvailableCompletedTreatmentAnal Condylomata / Anal Warts / HIV Positive / Human Immunodeficiency Virus (HIV) Infections1
Not AvailableEnrolling by InvitationPreventionHealthy Volunteers1
Not AvailableNot Yet RecruitingNot AvailableCancer of Cervix / Vaccinia1
Not AvailableNot Yet RecruitingNot AvailableHuman Papillomavirus (HPV)1
Not AvailableUnknown StatusNot AvailableChronic Kidney Disease, Stage IV (Severe) / Hemodialysis-dependent chronic kidney disease (HDD-CKD)1
Not AvailableUnknown StatusPreventionCancer, Anal / Human Immunodeficiency Virus (HIV) Infections1
Not AvailableUnknown StatusTreatmentGenital Human Papilloma Virus Infection1
Not AvailableWithdrawnNot AvailableHuman Papilloma Virus-Related Carcinoma1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, suspensionIntramuscular
SuspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on December 01, 2015 13:03 / Updated on June 12, 2020 10:53

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