A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

Inclusion Criteria:

Stage 1:

1. Female subjects 27-45 years of age (inclusive of 27 and 45 years of age);
2. Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
3. Subjects who understand and agree to comply with the study procedures and provide written informed consent;
4. Subjects who are able to comply with protocol-specified requirements;
5. Subjects with negative urine pregnancy test result at screening;
6. Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc.), or subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose and throughout the study;
7. Subjects with axillary temperature≤37.0℃.

Stage 2:

1. Female subjects 18-26 years of age (inclusive of 18 and 26 years of age);
2. Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
3. Subjects who understand and agree to comply with the study procedures and provide written informed consent;
4. Subjects who are able to comply with protocol-specified requirements;
5. Subjects with negative urine pregnancy test result at screening;
6. Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose and throughout the study;
7. Subjects with axillary temperature≤37.0℃.

Exclusion Criteria:

The same exclusion criteria apply to both stage 1 and stage 2

1. Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
2. Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
3. Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
4. Women who have known allergy history or who are allergic to any component of the interventions, such as penicillin and amikacin;
5. Women with a history of severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
6. Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;
7. Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past two years;
8. Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;
9. Women with a history of thyroidectomy or thyroid diseases that required medical care within the past 12 months.;
10. Women with serious angioedema episodes within the past 3 years or requiring medical care over the past 2 years;
11. Women who have hypertension over 145/95 mm Hg at enrolment despite being treated by medication;
12. Women with coagulation disorders as diagnosed by a doctor (e.g. coagulation factor deficiency, coagulopathy, or platelet disorder) or coagulation difficulty;
13. Women with active malignancy, or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study;
14. Women with a history of epilepsy other than epilepsy with febrile seizures under two years of age, epilepsy secondary to alcohol use 3 years prior to alcohol withdrawal, or a singular epileptic seizure not requiring treatment within the past 3 years;
15. Women with the condition of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen;
16. Women with a history of systematic chemotherapy in the past 5 years, a history of immunosuppressive therapy and cytotoxic therapy, and treatment with inhaled corticosteroids within the past 6 months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis), and women who received blood products in the 3 months prior to vaccination with the interventions;
17. Women who received a live attenuated vaccine during the 28 days prior to vaccination with the interventions; Women who received a subunit or inactivated vaccine, such as pneumococcal vaccine, or underwent antianaphylactic treatment during the 14 days prior to vaccination with the interventions;
18. Women who received a subunit or inactivated vaccine, such as pneumococcal vaccine, or underwent antianaphylactic treatment during the 14 days prior to vaccination with the interventions;
19. Women who are currently on an anti-TB prophylaxis or therapy;
20. Women who had fever (with axillary temperature≥38.0℃) during the 3 days prior to vaccination with the interventions or onset of any acute illness that required the use of antibiotics and antiviral treatment within the past 5 days;
21. Women with psychiatric conditions that preclude compliance with the protocol, or women with past or present psychoses, past or present bipolar disorder that has not been well controlled over the past 2 years, or women who are on medication for psychoses, or women who had suicidal thoughts/tendency in the past 5 years prior to enrolment;
22. Women with any medical, psychological or social conditions, or for occupational reasons or otherwise as judged by the principal investigator, that preclude participation in the study, or compromise a subject's ability to give informed consent.