• Kapan di booster ?

• KUSNANDI RUSMIL
Hasil Uji Klinis Fase III Vaksin Sinovac
Table 1 Demographic Data

Vaccine Placebo Total

Parameter
(N=405) (N=135) (N=540)
Mean age [years] (SD) 36.0 (11.5) 35.3 (10.9) 35.82 (11.4)
Mean height [m] (SD) 161.8 (8.9) 161.7 (9.8) 161.8 (9.2)
Mean weight [kg] (SD) 64.6 (13.2) 65.9 (13.6) 64.9 (13.3)
BMI (kg/m2) 24.6 (4.3) 25.2 (4.7) 24.75 (4.4)
Sex n(%)
Male 229 (56.5) 85 (63.0) 314 (58.15)
Female 176 (43.5) 50 (37.0) 226 (41.85)
Previous Education n(%)

Primary school 0 (0.0) 2 (1.5) 2 (0.37)

(some)
Primary school 12 (3.0) 2 (1.5) 14 (2.59)
(completed)
Junior high school 19 (4.7) 11 (8.1) 30 (5.56)
Senior high school 163 (40.2) 60 (44.4) 223 (41.30)
College or university 60 (14.8) 16 (11.9) 76 (14.07)
(diploma)
College or university 114 (28.1) 30 (22.2) 144 (26.67)
(bachelor)
Master’s or doctoral 37 (9.1) 14 (10.4) 51 (9.44)
degree
Ethnicity n(%)
Indonesia
Balinese 1 (0.25) 0 (0.00) 1 (0.19)
Batak 15 (3.70) 5 (3.70) 20 (3.70)
Buginese 1 (0.25) 0 (0.00) 1 (0.19)
Flores 1 (0.25) 0 (0.00) 1 (0.19)
Javanese 55 (13.58) 20 (14.81) 75 (13.89)
Madurese 1 (0.25) 1 (0.74) 2 (0.37)
Makassarese 1 (0.25) 0 (0.00) 1 (0.19)
Mbojo 1 (0.25) 0(0.00) 1 (0.19)
Malay 3 (0.74) 0(0.00) 3 (0.56)
Minahasa 1 (0.25) 0(0.00) 1 (0.19)
Minangkabau 6 (1.48) 3 (2.22) 9 (1.67)
Palembang 1 (0.25) 2 (1.48) 3 (0.56)
Sundanese 293 (72.35) 99 (73.33) 392 (72.59)
Foreign
Chinese 11 (2.72) 3 (2.22) 14 (2.59)
Arabs 1 (0.25) 0 (0.00) 1 (0.19)
>1 ethnic group 13 (3.21) 2 (1.48) 15 (2.72)
Table IgG Antibody Titer (ELISA) in V1, V3 and V3a between Vaccine and Placebo
*

Group
Time Point Parameter Vaccine Placebo p-value
(N = 397) (N = 133)
V1 Seropositive rate n(%) 44 (11.08) 14 (10.53) 0.859**)
(95% CI) (8.36 – 14.55) (6.37 – 16.89)

GMT*) 220.27 220.37 0.990***)

(95% CI) (212.87 – 227.93) (206.45 – 235.24)
Median 200.00 200.00
V3 Seropositive rate n(%) 396 (99.74) 7 (5.29) <0.001**)
(95% CI) (99.26 – 100) (1.47 – 9.06)

Seroconversion n(%) 387 (97.48) 1 (0.75) <0.001**)

(95% CI) (95.43 – 98.63) (0.13 – 4.14)

GMT*) 5181.19 223.61 <0.001***)

(95% CI) (4746.13-5656.14) (209.08-239.47)
Median 5333.35 200.00
V3a (N = 390) (N = 128)
Seropositive rate n(%) 387 (99.23) 13 (10.16) <0.001**)
(95% CI) (97.76 – 99.74) (6.03 – 16.60)

GMT*) 1605.90 229.17 <0.001***)

(95% CI) 1417.39-1819.45 210.04-250.05
Median 1235.95 200.00
 igG Antibody - Seropositive
100
80
60
40
20
0
Baseline (V1) 14 days post second 3 months post second
dose (V3) dose (V3a)
Vaccine Placebo
Table Neutralization Antibody in V1, V3, and V3a between Vaccine and Placebo
Group
Time Point Parameter p-value**)
Vaccine Placebo
(N = 397) (N = 133)
V1 Seropositive rate n(%) 0 0 -
(95% CI) (0 –0.96) (0 – 2.81)

GMT*) 2.00 2.00 -

(95% CI) - -
Median - -
V3 Seropositive rate n(%) 380 (95.72) 1 (0.75) <0.001**)
(95% CI) (93.25 – 97.31) (0.13 – 4.14)

Seroconversion n (%) 346 (87.15) 0 (0.00) <0.001**)

(95% CI) (83.50 – 90.09) (0 – 2.81)

GMT*) 15.76 2.02 <0.001***)

(95% CI) (14.57 – 17.04) (1.98 – 2.05)
Median 16 2

V3a (N = 390) (N = 128)

Seropositive rate n(%) 327 (83.85) 7 (5.47) <0.001**)
(95% CI) (79.87 – 87.17) (2.67 – 10.86)

GMT*) 7.12 2.19 <0.001**)

(95% CI) (6.55 – 7.74) (2.03 – 2.37)
Median 6.00 2.00
 Neutralizing antibody - Seropositive
100
80
60
40
20
0
Baseline (V1) 14 days post second 3 months post second
dose (V3) dose (V3a)
Vaccine Placebo
Immunogenicity and Safety of SARS-Cov-2 Protein
Subunit Recombinant Vaccine
(Bio Farma) :
as a Booster Dose
• Jumlah subjek: 840 subjek
• Sebanyak 840 subjek berusia ≥ 18 tahun yang
sudah menerima dosis primer vaksin COVID-
19 inaktif, mRNA, atau vector virus resmi/
disetujui direncanakan untuk direkrut, dimana
420 subjek masing-masing di rekrut di
Bandung, Jawa Barat dan Denpasar, Bali.
• Tujuan Primer:
• Mengevaluasi respon imun imunogenik non
inferioritas antibody SARS-CoV-2 (RBD)
binding IgG dari vaksin Bio Farma
dibandingkan dengan vaksin pembanding
pada 14 hari setelah pemberian dosis lanjutan
(booster).
 ASAL INSTANSI FK UNPAD

• MULTI CENTER
Protokol Studi
Judul Respons Kekebalan Tubuh dan Keamanan terhadap Vaksin
SARS-CoV-2 Protein Subunit Rekombinan (Bio Farma)
sebagai Dosis Lanjutan (Booster) pada Dewasa Sehat Usia
18 Tahun ke Atas
Sponsor PT Bio Farma
Vaksin Rekombinan Subunit Protein SARS-CoV-2 dengan Adjuvan
Alum + CpG 1018
Target Subjek 420 subjek
Desain studi Observer-blind, randomized, controlled trial
Trial Center
Peneliti Utama Nasional: Prof. Dr. Kusnandi Rusmil, dr., SpA(K), MM
Bandung Denpasar
Rumah Sakit Hasan Sadikin / Fakultas Departemen Kesehatan Anak
Kedokteran Universitas Padjajaran Universitas Udayana, RS Sanglah

Peneliti Utama: Peneliti Utama:

– Prof. Dr. Kusnandi Rusmil, dr., – Dr. dr. I Gusti Ayu Trisna Windiani,
SpA(K), MM SpA(K)
Flow Chart
Studi Booster
(n=420)

Vaksin Primer
Vaksin Primer Inaktif Vaksin Primer mRNA
Viral Vektor
(n=140) (n=140)
(n=140)

Vaksin Booster Vaksin Booster Vaksin Booster

Bio Farma Bio Farma Bio Farma
(n=70) (n=70) (n=70)

Vaksin Booster Vaksin Booster Vaksin Booster

Pfizer Pfizer Pfizer
(n=70) (n=70) (n=70)
 Objektif Studi - Primer
Mengevaluasi respon imun:
imunogenik non inferioritas SARS-CoV-2 (RBD) binding IgG
dari vaksin Bio Farma dibandingkan dengan vaksin
pembanding pada 14 hari setelah pemberian dosis
booster
 Jadwal Kunjungan
Hari 0 Hari 14 Hari 28 Hari 180
(V1) (V1+14hari (+4hari)) (V1+28hari (-4/+7hari)) (V1+6 bulan (+4 minggu))

Booster

Visit 1 Visit 2 Telpon 1 Visit 3

Kunjungan
Serologi

4 mL 4 mL 4 mL